National Cancer InstituteOffice of Cancer Complementary and Alternative Medicine

ANNUAL REPORT ON

COMPLEMENTARY 

AND ALTERNATIVE 

MEDICINE

FISCAL YEAR

2 0 1 0

U.S. DEPARTMENT 

OF HEALTH AND 

HUMAN SERVICES National Institutes 

of Health

1 DIRECTOR’S MESSAGE

DIRECTOR’S MESSAGE

T

he research the National Cancer 

Institute (NCI) supports, both 

in our own laboratories and 

at institutions worldwide, is 

focused on the ultimate goal of 

helping cancer patients. That 

mission – achieved through rigorous 

science – extends to NCI’s program on 

complementary and alternative medicine, 

also known as CAM. 

It is with great pleasure and pride that 

we once again provide NCI’s research 

partners, physicians, policymakers, cancer 

patients, and the advocacy community 

with this sixth annual review of NCI’s 

extensive accomplishments in advancing 

evidence-based CAM interventions and 

therapies. 

Among the highlights of NCI’s CAMrelated activities in fiscal year (FY) 2010, 

was the collaboration between NCI, the 

National Institutes of Health’s Office of 

Dietary Supplements (ODS), and the 

National Center for Complementary and 

Alternative Medicine (NCCAM) to cofund two Botanical Research Centers. 

The Botanical Research Centers Program 

aims to promote collaborative, integrated, 

interdisciplinary study of botanicals, 

particularly those found as ingredients 

in dietary supplements, and to conduct 

research with high potential for being 

translated into practical benefits for 

human health. The two centers co-funded 

by NCI are located at the University 

of Illinois at Urbana-Champaign and 

the University of Missouri. The NCIfunded centers will research botanical 

products used in the fight against cancer, 

specifically breast and prostate cancer.

NCI’s commitment to CAM research 

and clinical practice has been steadily 

supported, coordinated, and expanded by 

the Office of Cancer Complementary and 

Alternative Medicine (OCCAM) over the 

years. OCCAM’s goal is to increase NCI’s 

ability to extend the search for effective 

therapies into areas that show promise, 

but which often are not thoroughly 

explored in conventional biomedical 

research.

I hope you find this report helpful 

and informative. I also hope that it 

will generate an enhanced dialogue – 

especially between patients and health 

care professionals – about the appropriate 

uses of CAM interventions in conjunction 

with conventional medicine. Cancer 

patients deserve credible, unbiased 

information about any intervention or 

treatment regimen they are considering. 

It is our duty to conduct and support the 

science that makes wise and informed 

decisions possible.

Jeffrey D. White, M.D.

Director

Office of Cancer Complementary 

and Alternative Medicine

Division of Cancer Treatment and Diagnosis

National Cancer Institute
The following acronyms are used throughout this report: 

NCI National Cancer Institute

FY Fiscal Year

CAM complementary and alternative medicine

OCCAM Office of Cancer Complementary and Alternative Medicine

NIH National Institutes of Health

DCB Division of Cancer Biology

DCCPS Division of Cancer Control and Population Sciences

DCP Division of Cancer Prevention

DCTD Division of Cancer Treatment and Diagnosis

CCR Center for Cancer Research

DCEG Division of Cancer Epidemiology and Genetics

BRC Botanical Research Center

ODS Office of Dietary Supplements

NCCAM National Center for Complementary and Alternative Medicine

MOU Memorandum of Understanding

ERP Extramural Research Program 

COP Communications and Outreach Program

CRISP Case Review and Intramural Science Program

ARRA American Recovery and Reinvestment Act

FOA funding opportunity announcement

CARRA Consumer Advocates in Research and Related Activities

BCS Best Case Series

PDQ® Physician Data Query®

CIS Cancer Information Service

CRTA Cancer Research Training Award

2 NCI CAM ANNUAL REPORT 2010
3 NCI CAM ANNUAL REPORT 2010 

CONTENTS

Director’s Message 1

Introduction 5

NCI CAM Research Funding Portfolio Analysis: FY 2010 6

NCI Collaborative Partnerships Supporting Complementary and Alternative Medicine 12

Office of Cancer Complementary and Alternative Medicine (OCCAM) 14

NCI CAM Communications Programs 22

Training and Conferences 28

NCI Research in Complementary and Alternative Medicine

Highlights from NCI’s CAM Training Projects 32

Exercise Researcher Refocuses Career on Cancer Prevention and Control Studies 34

Curcumin Investigated to Prevent Prostate Cancer Metastasis 35

Highlights from NCI’s CAM Research 36

Understanding the Causes and Mechanisms of Cancer 37

Compound in Red Sage Plant May Help Control Blood Vessels that Feed Tumors 38

Scientists Study Biomarkers of High-Fiber Diets to Lower Risk of Colorectal Cancer 40

Researchers Study Whether Altering Cellular Fats Raises Cancer Risk 42

Milk Thistle Extract Evaluated Against Cancer-Causing Liver Disease 43

Accelerating Progress in Cancer Prevention 44

Exercise May Stop Cancer from Spreading to the Brain 46

Compound in Cruciferous Vegetables Studied Against Pancreatic Cancer 47

Vitamin A Studied as Possible Preventive Agent Against Cancer 48

Vitamin D Tested for Preventing Lung Cancer in High-Risk Patients 49

Black Raspberries Studied To Prevent Oral Cancer 50

Developing Effective and Efficient Treatments 52

Special Electric Signals Attack Cancer Cells with Lethal Force and Accuracy 54

Soy Bread Studied in Men with Prostate Cancer 55

Clinical Trial Inspired by Breast Cancer Cells, Cows, and Collaboration 56

Improving the Quality of Life for Cancer Patients, Survivors, and their Families 58

Yoga Studied to Relieve Fatigue and Stress in Breast Cancer Patients 60

Electroacupuncture May Counter Patients’ Nausea After Chemotherapy 61

Behavioral Stress Management Program, Even in Small Doses, 

May Help Breast Cancer Patients 62

Tai Chi Exercise Studied to Improve Quality of Life for Senior Cancer Survivors 63

Scientific Publications 64

Appendix 66
4 NCI CAM ANNUAL REPORT 2010

Figure 1. Major Categories of CAM Therapies

Alternative Medical Systems 

Definition: Alternative medical systems are built 

upon complete systems of theory and practice. 

Often, these systems have evolved apart from and 

earlier than the conventional medical approach used 

in the United States. 

Examples: Acupuncture, Ayurveda, Homeopathy, 

Naturopathy, Traditional Chinese Medicine, Tibetan 

Medicine 

Energy Therapies

Definition: Energy therapies involve the use of 

energy fields. There are two types: 

• Biofield therapies are intended to affect energy 

fields that purportedly surround and penetrate the 

human body. The existence of such fields has not 

yet been scientifically proven.

Examples: Qi gong, Reiki, Therapeutic touch 

 • Electromagnetic-based therapies therapies involve 

the unconventional use of electromagnetic fields, 

such as pulsed fields, magnetic fields, or alternating 

current or direct current fields. 

Examples: Pulsed electromagnetic fields, Magnet 

therapy 

Exercise Therapies

 Definition: Exercise therapies include health-enhancing systems of exercise and movement.

 Examples: T’ai chi, Yoga asanas

Manipulative and Body-Based Methods 

 Definition: Manipulative and body-based methods in 

CAM are based on manipulation and/or movement 

of one or more parts of the body.

Examples: Chiropractic, Therapeutic massage, 

Osteopathy, Reflexology 

Mind-Body Interventions 

 Definition: Mind-body medicine uses a variety of 

techniques designed to enhance the mind’s capacity 

to affect bodily function and symptom. 

Examples: Meditation, Hypnosis, Art therapy, 

Biofeedback, Imagery, Relaxation therapy, Support 

groups, Music therapy, Cognitive-behavioral therapy, 

Aromatherapy 

Nutritional Therapeutics

Definition: Nutritional therapeutics are an assortment of nutrients and non-nutrients, bioactive food 

components used as chemo-preventive agents, and 

specific foods or diets used as cancer prevention or 

treatment strategies.

 Examples: Macrobiotic diet, Vegetarianism, Gerson 

therapy, Kelley/Gonzalez regimen, Vitamins, 

Soy phytoestrogens, Antioxidants, Selenium, 

Coenzyme Q10 

Pharmacological and Biologic Treatments 

 Definition: Pharmacological and biologic treatments 

include the off-label use of certain prescription 

drugs, hormones, complex natural products, 

vaccines, and other biological interventions not 

yet accepted in mainstream medicine. 

 Examples: Antineoplastons, 714X, Low-dose naltrexone, Immunoaugmentative therapy, Laetrile, 

Hydrazine sulfate, Melatonin 

Sub-category: Complex Natural Products

Definition: Complex natural products are an assortment of plant samples (botanicals), extracts of crude 

natural substances, and un-fractionated extracts from 

marine organisms used for healing and treatment of 

disease. 

Examples: Herbs and herbal extracts, Mistletoe, 

Mixtures of tea polyphenols, Shark cartilage 

Spiritual Therapies 

Definition: Spiritual therapies are therapies that focus 

on deep, often religious beliefs and feelings, including a person’s sense of peace, purpose, connection 

to others, and beliefs about the meaning of life. 

Examples: Intercessory prayer, Spiritual healing 

2010
5 

INTRODUCTION

T

his report highlights the National Cancer Institute’s initiatives and annual expenditures in 

complementary and alternative 

medicine (CAM)* research. It is 

intended as a way for NCI to 

communicate its progress in this area of 

medical research to all interested stakeholders including cancer researchers, CAM 

practitioners, health care providers, advocacy organizations, cancer patients and the 

general public.

Similar to the previous reports, this 

publication provides an overview of 

the NCI-supported work in this field 

along with details on selected projects 

in the areas of cancer CAM relating to 

communication, training and conferences, 

and research. For more information on 

specific projects included in this report 

please visit the NIH Research Portfolio 

Online Reporting Tools (RePORTER) 

database (http://projectreporter.nih.gov/

reporter.cfm) and search the grant or 

project number. 

This report highlights projects, grants, 

and cooperative agreements supported 

by each of the Institute’s extramural 

grant funding divisions – Division of 

Cancer Biology (DCB), Division of Cancer 

Control and Population Sciences (DCCPS), 

Division of Cancer Prevention (DCP), and 

the Division of Cancer Treatment and 

Diagnosis (DCTD), along with projects 

from NCI’s intramural laboratories in the 

Center for Cancer Research (CCR) and 

the Division of Cancer Epidemiology 

and Genetics (DCEG). These projects 

represent a variety of CAM categories, 

cancer types, research types, and grant 

mechanisms. Also included in the report 

is a breakdown of NCI’s CAM research 

portfolio. In FY 2010, NCI’s research 

expenditures for CAM were an estimated 

$114,460,116 for the funding of 406 CAM 

research projects. In addition, during FY 

2010, NCI used $6,646,594 in funds from 

the American Recovery and Reinvestment 

Act (ARRA) to award 27 CAM research 

grants.

As this report on cancer CAM indicates, 

we at the NCI are committed to an 

integrated approach to bring together all 

of the many resources and approaches 

necessary to decrease the frequency, 

destructiveness, and lethality of cancer. 

We believe that evidence-based CAM 

techniques, systems, and products can 

have an important role in reaching that 

worthwhile goal.

* CAM is often defined as any medical system, practice, or product that is not thought of as “western medicine” or standard 

 medical care. Complementary medicine is used along with standard medicine, also called conventional medicine. Alternative 

medicine is used in place of standard treatments. CAM treatments may include dietary supplements, megadose vitamins, herbal 

preparations, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation. (See Figure 1, on page 4 for the 

major categories of CAM therapies.)

INTRODUCTION
NCI CAM Research Funding Portfolio Analysis:

FY 2010

6 NCI CAM ANNUAL REPORT 2010
THE CAM PORTFOLIO ANALYSIS PROCESS

How much money does NCI spend on CAM research each year? This is one of 

the questions most frequently posed to OCCAM. Researchers, cancer patient 

advocates, proponents of CAM, and Congress are interested in the answer, and 

OCCAM is responsible for gathering the data needed to report the total CAM 

expenditures budget figure each year. 

It is a common misconception that OCCAM manages all of the CAM projects 

for NCI. The vast majority of CAM projects are managed by other programs and 

laboratories throughout the Institute. After the close of the fiscal year, NCI’s 

Division of Extramural Activities (DEA) provides OCCAM with a list of funded 

grants and cooperative agreements coded as containing some component 

of CAM research. Similarly, NCI’s two intramural components, the Center for 

Cancer Research (CCR) and the Division of Cancer Epidemiology and Genetics 

(DCEG), provide lists of their potentially relevant projects. Also, a list of 

contracts identified as potentially containing CAM research is provided. OCCAM 

staff review each project to confirm they are accurately classified as CAM 

research. Then aspects of each project are identified allowing their placement 

into sub-categories based on the type of research and CAM intervention 

investigated.

NCI’s total CAM expenditure figure includes money awarded for intramural 

projects (projects conducted within NIH facilities and labs), extramural grants 

(projects conducted outside of NIH), cooperative agreements, contracts, and 

supplements. It is important to note the reported figure for total NCI CAM 

expenditures for a fiscal year only includes projects for which NCI is the 

primary funder.

7 NCI CAM RESEARCH FUNDING PORTFOLIO ANALYSIS: FY 2010
8 NCI CAM ANNUAL REPORT 2010
9 NCI CAM RESEARCH FUNDING PORTFOLIO ANALYSIS: FY 2010 

Total Estimated Cancer CAM 

Research Expenditure

In FY 2010, NCI invested $114,460,116 for 406 intramural 

and extramural research projects relevant to CAM. For the 

purpose of the FY 2010 analysis, the following types of 

funding are included: intramural projects and extramural 

grants, cooperative agreements, contracts, and supplements 

(Figure 3).

In addition, during FY 2010, NCI used $6,646,594 in 

funds from the American Recovery and Reinvestment Act 

(ARRA) to award 27 CAM research grants.

The above numbers do not include CAM training grants 

(T and F awards), K (research career) or R25 (cancer 

education) grants. These numbers are listed separately 

in Figure 4. 

Grant Awards by Funding 

Opportunity Announcement

In FY 2010, there were 65 funding opportunity 

announcements (FOA) that yielded cancer CAM grants. 

The program announcement (PA) “Research Project 

Grants (Parent R01)” (PA-07-070) was the most productive 

mechanism for attracting new CAM grants to NCI. A total 

of 85 of the 238 CAM grants awarded through FOAs in 

FY 2010 came to NCI through this announcement 

(Figure 5).

Figure 3. NCI CAM Expenditures: FY 2003-2010*

Millions

$130 $128,671,113

$125

$123,076,167 $121,076,919 $121,932,765 $121,264,507 $119,900,000 $120

$114,460,116 $114,441,501 $115

$110

$105

2003 2004 2005 2006 2007 2008 2009 2010

* Includes grants, cooperative agreements, intramural projects, and contracts. Grants and cooperative agreements are only included when NCI is the primary funding agency. 

Excludes training grants (Ts, Fs, Ks, and R25s) and ARRA funds. Total projects include all active projects in FY 2010.

Figure 4. NCI CAM Training Projects 2010

Training Grant Mechanisms Number of Grants Total Funding

F (31, 32) 3 $ 48,892

K (01, 05, 07, 22, 23, 24) 19 $ 1,427,308

R25 4 $ 782,445

T32 1 $ 46,140

TOTAL 27 $2,304,785

Note: does not include ARRA funded projects. 
10 NCI CAM ANNUAL REPORT 

Breakdown by Research Type

The accompanying pie-chart (Figure 6) shows the 

distribution of the projects by prevention, treatment, 

symptom/side effects management, epidemiology, 

and conferences. In FY 2010, 61.5% of cancer CAMrelated research project funds went to various cancer 

prevention efforts, while treatment, symptom/side effects 

management, epidemiology, and conferences received 

19.7%, 11.2%, 7.5%, and 0.004% respectively.

Breakdown by Major CAM Therapy Category

In FY 2010, NCI performed or supported research 

addressing a variety of CAM approaches (Figure 7). These 

CAM therapies fall into nine groups: alternative medicine 

systems, energy therapies, exercise therapies, manipulative 

and body-based methods, mind-body interventions, 

nutritional therapeutics, pharmacological and biologic 

treatments, spiritual therapies, and miscellaneous. 

(See page 4 for definitions of CAM categories.)

Figure 5. Number of Grant Awards by Funding Opportunity Announcement

Funding Announcement Number 

of Grants

2010

AT03-002 2

AT08-003 1

CA04-004 1

CA05-001 1

CA05-013 2

CA05-014 1

CA07-025 6

CA08-004 1

CA09-022 2

HL08-013 1

PA04-046 1

PA04-099 2

PA05-027 1

PA05-040 1

PA05-125 2

PA06-042 1

PA06-283 1

PA06-303 1

PA06-314 2

PA06-315 5

PA06-351 4

PA06-400 3

PA06-412 3

PA06-413 4

PA06-414 1

PA06-440 1

PA06-510 8

PA07-007 3

PA07-046 1

PA07-070 85

PA07-100 2

PA07-174 1

PA07-175 4

PA07-176 1

PA07-177 1

PA07-257 2

PA07-258 1

PA07-280 1

PA07-320 1

PA07-356 1

PA07-362 8

PA08-032 1

PA08-051 1

PA08-074 1

PA08-121 1

PA08-149 1

PA08-185 4

PA08-208 2

PA08-209 1

PA08-210 1

PA08-220 2

PA09-010 3

PA09-149 1

PA09-167 3

PA10-067 1

PAR05-156 4

PAR06-294 2

PAR06-313 13

PAR06-458 1

PAR06-505 1

PAR08-020 1

PAR08-055 14

PAR08-135 4

PAR08-237 3

PAR09-025 1

Total Solicited 238

Total 

Unsolicited 137

TOTAL GRANTS

AWARDED 375

Figure 6. NCI CAM Research Projects by 

Research Type*

Prevention

$70,430,893

61.5% 

Treatment

$22,536,211

19.7% 

Symptom/Side-Effect 

Management 

$12,870,721

11.2% 

Epidemiology 

$8,617,290

7.5%

Conferences

$5,000

0.004%

* Includes grants, cooperative agreements, intramural projects, and contracts. Grants 

and cooperative agreements are only included when NCI is the primary funding agency. 

Excludes training grants (Ts, Fs, Ks, and R25s) and ARRA funds. Total projects include 

all active projects in FY 2010.

Figure 7. NCI CAM Research Projects by CAM Category*

72.9%

Nutritional 

Therapeutics

$83,406,368

11%

Pharmacological and 

Biologic Treatments

$12,536,563

5.9%

Exercise Therapies

$6,803,003

3.8%

Mind-Body 

Interventions

$4,317,855

3.1%

Miscellaneous

$3,592,695

1.6%

Alternative 

Medical Systems

$1,855,391

.9%

Energy Therapies

$998,867

.5%

Spiritual Therapies

$581,853

.3%

Manipulative & Body-Based 

Methods

$367,521
11 NCI CAM RESEARCH FUNDING PORTFOLIO ANALYSIS: FY 2010

The largest percentage (72.9%) of CAM research funding 

went to projects that investigated nutritional therapeutics, 

which can be further broken out into subcategories of 

research on: foods (e.g., broccoli and berries); minerals 

(e.g., calcium and selenium); vitamins (e.g., vitamins C 

and D); bioactive food components (e.g., isoflavones and 

carotenoids); dietary regimens (e.g., caloric restriction and 

high fruits and vegetables); fats (e.g., linoleic acid and 

omega-3); and amino acids and proteins (e.g., N-acetyl 

cysteine and glycine).

Figure 8 shows the distribution of projects by the 

subcategories of nutritional therapeutics.

Breakdown by Cancer Type

The research projects that make up NCI’s FY 2010 CAM 

research portfolio address 17 categories of cancer types. 

Among the various categories, prostate, breast, colorectal, 

and lung cancers received the largest amounts of cancer 

CAM research funding. Nearly 28% of NCI’s cancer CAM 

research funding supported projects addressing “multiple 

types” of cancer.

For a complete listing of the cancer type categories and 

estimated funding amounts, please see Figure 9 below.

Figure 8. NCI CAM Nutritional Therapeutics Projects 

by Category*

Bioactive Food 

Component

$31,552,097

37.8% 

Vitamins

$20,110,868

24.1%

Minerals 

$17,101,163 

20.5% 

Fats

$5,372,147

6.4%

Dietary Regimens 

$4,555,775

5.5%

Food

$4,062,349

4.9%

Amino Acids and 

Proteins

$651,969 

0.8%

* Includes grants, cooperative agreements, intramural projects, and contracts. Grants 

and cooperative agreements are only included when NCI is the primary funding agency. 

Excludes training grants (Ts, Fs, Ks, and R25s) and ARRA funds. Total projects include 

all active projects in FY 2010.

Figure 9. NCI CAM Research Projects by Cancer Type*

Cancer Amount

Bladder $1,257,201

Brain $308,138

Breast $16,092,015

Cervical $1,124,471

Childhood Cancer $544,632

Colorectal $14,868,217

Esophageal $1,535,074

Gastric $1,714,307

Head and Neck $2,989,885

Hematologic $2,128,574

Liver $1,114,248

Lung $10,001,521

Multiple Types $31,728,976

Pancreatic $3,140,236

Prostate $20,832,378

Skin: Melanoma and Non-Melanoma $5,030,124

Small Intestine $50,119

TOTAL: $114,460,116

* Includes grants, cooperative agreements, intramural projects, and contracts. Grants and cooperative 

agreements are only included when NCI is the primary funding agency. Excludes training grants 

(Ts, Fs, Ks, and R25s) and ARRA funds. Total projects include all active projects in FY 2010.
NCI Collaborative Partnerships Supporting 

Complementary and Alternative Medicine

Botanicals Research

The Botanical Research Center (BRC) Program 

was established in 1999 by the Office of 

Dietary Supplements (ODS) to provide 

funding for United States research centers 

to investigate the safety, effectiveness, and 

biology of botanical products. The awards, 

worth approximately $1.5 million each year 

for 5 years, are jointly funded by ODS and 

the National Center for Complementary and 

Alternative Medicine (NCCAM). In FY10, the 

NCI co-supported two of the five centers 

selected. The NCI-supported centers are 

located at the University of Illinois at UrbanaChampaign and the University of Missouri.

As women approach menopause, estrogen 

levels in their bodies decrease. Many women 

look to botanical estrogens (such as wild 

yam, soy, and dong quai) as safe and natural 

replacements for the estrogen they are losing. 

However, estrogens have a variety of effects on 

cells and not much is known about the exact 

actions of botanical estrogens. At the Botanical 

Estrogens: Mechanisms, Dose, and Target 

Tissues Center (University of Illinois at UrbanaChampaign) researchers are investigating how 

12 NCI CAM ANNUAL REPORT 2010
plant-derived estrogens affect molecular 

and cellular activity and see how similar 

(or how different) they are to estrogens 

naturally found in the body. In addition 

this BRC, which is headed by William 

Helferich, Ph.D., will determine how 

botanical estrogens affect breast cancer 

metastasis. 

The Center for Botanical Interaction 

Studies at the University of Missouri also 

received support from the BRC program 

in FY10. The principal investigator of 

this center is Dennis Lubahn, Ph.D. One 

of the research projects at this center 

focuses on actions by commonly-used 

botanical dietary supplements on five 

signaling pathways, which may have 

chemopreventive effects. The botanicals 

that will be studied at this BRC include 

garlic, soy, sutherlandia (a medicinal 

plant from Africa), picrorhiza (a plant 

found in the Himalayan mountains), and 

elderberry. The researchers hope to gain 

a better understanding of exactly how 

these botanicals may act to help prevent 

prostate cancer. 

Intramural Research Collaboration with 

Chinese Academy of Sciences

In March 2010, NCI signed a Memorandum of Understanding (MOU) with the 

Key Laboratory of Chemistry for Natural 

Products of Guizhou Province and Chinese Academy of Sciences, China. The 

MOU states that the Key Laboratory will 

provide compounds and extracts isolated 

from Traditional Chinese Medicine, folk/

tribal medicine, and other Guizhou-area 

specific botanicals to NCI for anti-cancer 

activity screening and other cellular pathway functional assays. 

Currently, a group of 243 chemical compounds with determined structures 

isolated at the Guizhou Key Laboratory 

are being studied via the NCI 60 human 

cancer cell line screen for growth inhibitory activity, as well as in cellular pathway 

analysis studies targeting specific cellular 

signaling, and metabolic pathways involved in growth of cancers. Research for 

this partnership is ongoing. 

13 NCI COLLABORATIVE PARTNERSHIPS SUPPORTING COMPLEMENTARY AND ALTERNATIVE MEDICINE
14 NCI CAM ANNUAL REPORT 

Office of Cancer Complementary and 

Alternative Medicine (OCCAM)

2010
15 

NCI’s Office of Cancer Complementary and Alternative Medicine (OCCAM) 

is a coordinating office responsible for: identifying gaps in the science 

and creating corresponding funding opportunities for cancer CAM 

research; partnering with NCI program staff and other governmental and 

nongovernmental organizations to increase the testing of CAM approaches 

for cancer prevention, diagnosis, treatment, symptom management, and 

rehabilitation; developing communication products for various audiences 

concerning the investigation and use of these approaches; and helping 

to build bridges between CAM practitioners and the cancer research 

community.

OCCAM is part of the NCI Division of Cancer Treatment and Diagnosis 

(DCTD); (http://dctd.cancer.gov). The division’s mission is to improve the 

lives of the American public by discovering and conducting better ways to 

diagnose, assess, treat, and cure cancer through stimulating, coordinating, 

and funding a national program of cancer research. OCCAM’s programs and 

activities complement DCTD’s mission and are enhanced by the other major 

programs and branches within DCTD.

OCCAM’s research priorities include: 

•	 Identifying novel therapeutics in the pharmacopeia of traditional medical 

systems as defined by the World Health Organization 

•	 Research of complementary approaches to improve the therapeutic ratio 

of standard and investigational anti-cancer therapies

•	 Research on lifestyle modifications (e.g., diet, exercise, mind-body 

approaches) for their impact on cancer outcomes (e.g., response to 

conventional cancer therapy, survival)

OFFICE OF CANCER COMPLEMENTARY AND ALTERNATIVE MEDICINE (OCCAM)
16 NCI CAM ANNUAL REPORT 2010

OCCAM Programs

In April 2010 OCCAM changed the names of two of 

its programs. The Research Development and Support 

Program was changed to the Extramural Research 

Program or ERP, and the Practice Assessment Program 

was changed to the Case Review and Intramural Science 

Program or CRISP. Activities, staff, and organizational 

structure of each program remain the same. For more 

information about each program, visit: http://www.cancer.

gov/cam/about_programs.html.

Extramural Research Program

OCCAM’s Extramural Research Program (ERP) staff 

manages a portion of NCI’s CAM research portfolio, 

works with other program staff throughout NCI on CAM 

research issues, assists investigators in identifying funding 

opportunities, and provides guidance to applicants in the 

pre- and post-review periods of grant applications. The 

staff also coordinates programs and initiatives designed 

to stimulate research in cancer CAM, as well as activities 

to develop the foundation of the science in cancer CAM 

research.

ERP continues to support funding opportunity announcements (FOAs) for small grant mechanisms: R21 and R03. 

The R21 funding opportunities encourage and support 

the development of basic and clinical complementary and 

alternative cancer research projects (prevention, therapeutic, and palliative) through exploratory/developmental 

research grants. The R03 mechanism offers researchers a 

chance to generate data needed for conducting larger scientific studies of CAM. OCCAM continues to encourage 

new and young, as well as seasoned veteran investigators 

to pursue research in areas not typically explored in studies 

funded by larger grant mechanisms. R21 and R03 grants 

provide that opportunity. 

More information about these FOAs is available online:

•	 Developmental Projects in Complementary 

Approaches to Cancer Care and Treatment (R21) 

PA-09-167 

http://grants.nih.gov/grants/guide/pa-files/

PA-09-167.html

•	 Developmental Projects in Complementary 

Approaches to Cancer Care and Treatment (R03) 

PA-09-168

http://grants.nih.gov/grants/guide/pa-files/

PA-09-168.html

In FY10, NCI co-sponsored three new program 

announcements which specifically solicited CAM-related 

research:

•	 Biology of Manual Therapies (R01) PA-10-209

http://grants.nih.gov/grants/guide/pa-files/

PA-10-209.html

•	 Biology of Manual Therapies (R21) PA-10-210 

http://grants.nih.gov/grants/guide/pa-files/

PA-10-210.html

•	 Limited Competition: Fogarty International Research 

Collaboration – Basic Biomedical (FIRCA-BB) 

Research Award (R03) PAR-11-037

http://grants.nih.gov/grants/guide/pa-files/PAR-11-

037.html
17 OFFICE OF CANCER COMPLEMENTARY AND ALTERNATIVE MEDICINE (OCCAM)

Highlights from OCCAM’s grant portfolio

In FY 2010, OCCAM provided a competitive supplement 

to a cooperative agreement held by Dr. Lorenzo Cohen 

at M.D. Anderson Cancer Center (U19CA121503-04S1) 

in support of the International Center of Traditional 

Chinese Medicine for Cancer (ICTCMC), which is jointly 

coordinated by the M.D. Anderson Cancer Center in 

Houston, TX and the Cancer Hospital, Fudan University 

in Shanghai, China. The supplement supports ICTCMC’s 

work on the use of Huachansu (a toad skin extract) in 

pancreatic cancer patients and is given with gemcitabine 

(a commonly used conventional chemotherapy) and 

radiotherapy. Huachansu was tested for efficacy via 

documentation of tumor response rate, 6 month survival, 

safety and toxicity, and changes in quality of life in patients. 

More information about this project is available by searching the NIH Research Portfolio Online Reporting Tools 

database (http://projectreporter.nih.gov/reporter.cfm).

A competitive supplement was also awarded to Dr. 

Yung Chi-Cheng of Yale University (U01CA063477-

14S2) for work on the project titled “Nucleoside 

Analogs as Anticancer Compounds” that aims to develop 

deoxynucleoside analogs for the treatment of cancer. 

More information is available at the NCI Funded Research 

portfolio: http://fundedresearch.cancer.gov/search/

details?action=abstract&grantNum=3U01CA063477-

14S2&grantID=8047232&grtSCDC=FY%202010&absID=79

17406&absSCDC=CURRENT

During FY10 a grant managed by OCCAM received 

supplemental funding from NIH’s Office of Dietary 

Supplements (ODS). This collaborative effort marks 

the first time that ODS has co-funded an OCCAMmanaged grant. The supplemental funding for the R21 

grant (3R21CA138277-03s1) titled “Ginger Extract: 

Bioavailability Study and Lung Cancer Preventive 

Effect” will support detailed study on the bioavailability, 

biotransformation, and metabolic profile of ginger extract 

and its key constituents by fully utilizing the samples 

collected in the parent project. The parent project of this 

R21 supplement seeks to study the biological activities of 

ginger extract and its key constituents, [6]-gingerol and 

[6]-shogaol, and develop a ginger extract containing high 

levels of shogaols as a lung cancer preventive agent.

More information is available: http://fundedresearch.

cancer.gov/search/details?action=abstract&grantNum=3

R21CA138277-03S1&grantID=8148074&grtSCDC=FY%20

2010&absID=8148074&absSCDC=CURRENT

Communications and Outreach Program

OCCAM’s Communications and Outreach Program (COP) 

develops and disseminates information about NCI program 

initiatives and funding opportunities, workshops and other 

events, and educational materials through OCCAM’s publications and Web site (http://www.cancer.gov/cam).

This program also assesses the opinions, interests, and informational needs of cancer researchers, CAM practitioners, 

and cancer patients regarding CAM approaches and CAM 

research through surveys, public comment sessions, and 

focus groups. Results from these explorations are used to 

guide outreach efforts to these communities.

Major communication initiatives in FY 2010 included:

•	 Participation in Open Call usability testing with the 

NCI Office of Communication and Education for the 

new NCI CAM Portal website.

•	 Launch of an inventory project that assessed the 

research, education, and clinical practice of NCIdesignated Cancer Centers and their affiliated or 

stand alone Integrative Medicine Centers throughout 

the United States. Information gathered from this 

inventory will be used to understand the unique 

research and educational issues that surround NCIdesignated Cancer Centers and Integrative Medicine 

Centers and how the Centers can best serve patients 

interested in complementary and alternative medicine.
18 NCI CAM ANNUAL REPORT 2010

•	 COP assisted in the development of a complementary 

and alternative medicine YouTube video featuring 

OCCAM Director Dr. Jeffrey D. White. This video 

is part of the NCI LifeLines video series and is 

available on YouTube: http://www.youtube.com/

watch?v=zPgUiBPp9mY and the OCCAM website 

(http://www.cancer.gov/cam).

COP exhibit program 

In addition to sending staff and publications to 

professional meetings of interest to the field of cancer 

complementary and alternative medicine, COP also 

exhibits at key conferences. The exhibit program increases 

awareness of OCCAM and NCI funding opportunities 

in cancer CAM to the research, CAM practitioner, and 

academic communities. Goals of the program include 

soliciting new grant applications, engaging with patient 

communication professionals, and connecting members 

of OCCAM with relevant researchers, practitioners, and 

patients in the community.

Conferences in which OCCAM exhibited and/or sent 

representatives or materials:

•	 6th International Conference of the Society 

for Integrative Oncology, November 2009, 

New York, NY 

•	 Annual Meeting of the American Public Health 

Association, November 2009, Philadelphia, PA 

•	 Evidence-Based Complementary and Alternative 

Cancer Therapies Conference, January 2010, 

West Palm Beach, FL

•	 Integrative Health Care Symposium, February 2010, 

New York, NY 

•	 International Congress for Complementary Medicine 

Research, May 2010, Tromsø, Norway

•	 Association of Naturopathic Physicians Annual 

Conference, August 2010, Portland, OR

COP organized publication support at the following

meetings:

•	 Oncology Nursing Society, May 2010, San Diego, CA

•	 American Society for Clinical Oncology, June 2010, 

Chicago, IL

•	 American Association of Cancer Research, April 2010, 

Washington, DC

•	 Institute for Functional Medicine, May 2010, 

Carlsbad, CA

In FY 2010, cancer patient advocates were involved in the 

review of NCI’s CAM Annual Report. OCCAM solicited 

feedback from four Consumer Advocates in Research 

and Related Activities (CARRA) members who agreed 

to review a draft of the FY 2009 report. These members 

provided comments on whether the document was easy 

to read, contained relevant information to the cancer 

patient community, or omitted topics of patient interest. 

The feedback from these CARRA members improved the 

quality of the NCI’s Annual Report on Complementary 

and Alternative Medicine: Fiscal Year 2009

(http://www.cancer.gov/cam/attachments/nci_cam_

annual_report_fy09.pdf).

Case Review and Intramural Science Program

The mission of the Case Review and Intramural Science 

Program (CRISP) is to identify and develop novel 

complementary and alternative (CAM) therapies for the 

treatment of cancer. This aim is implemented through 

various program activities, such as the rigorous scientific 

evaluation of retrospective case reports (NCI Best Case 

Series Program) and round table discussions, with the 

ultimate goal of identifying those CAM interventions 

that have enough evidence to support NCI-initiated 

prospective research. 
19 OFFICE OF CANCER COMPLEMENTARY AND ALTERNATIVE MEDICINE (OCCAM)

NCI Best Case Series new protocol

During FY10, in response to a request from the NIH Office of Human Subjects Research (OHSR) and Office for 

Human Research Protection (OHRP), the long-standing 

NCI Best Case Series (BCS) Program was converted to a 

research protocol. Under the new protocol, the OCCAM 

investigators (Drs. Zia and Olaku) will provide the CAM 

practitioner with a “mini-consent” form to document that 

a patient, whose medical case history is being considered 

for submission, agrees to the release of their basic contact 

information (such as name and telephone number) to 

OCCAM. Once OCCAM receives this “mini-consent,” 

one of the BCS investigators will contact the patient to 

review and complete the protocol consent. In essence, 

this is a written consent allowing the patient’s identified 

medical records to be reviewed as part of this retrospective 

case study. This step is an important requirement for the 

new protocol – it ensures that all of the patients receive 

accurate and consistent information regarding the Program and it makes clear that their medical records will be 

viewed by different people associated with the program 

(including the BCS investigators, pathologists, radiologists, and external reviewers). Overall, the NCI Best Case 

Series Submission Criteria remain the same with the only 

other change being that practitioners must submit from 

3 to 20 cases (prior to the new protocol, there were no 

restrictions on the number of cases submitted by a practitioner). The protocol received final approval by the Special 

Studies Institutional Review Board (IRB) and by the NIH 

Clinical Center Director in early FY11.

In FY 2010, 13 cases of cancer patients treated with an 

alternative approach were submitted to the NCI Best Case 

Series Program and reviewed for eligibility.

CRISP highlights

In June 2010, CRISP facilitated a meeting of researchers 

and clinicians to discuss cases of cancer patients treated 

with a metal-based Ayurvedic treatment submitted to the 

NCI Best Case Series Program. Cases were submitted by 

Vaidya Balendu Prakash, an Ayurvedic practitioner from 

Mumbai, India. The meeting provided an opportunity for 

NCI staff and outside experts to review and discuss the 

case reports and possible future collaborations as a result of 

the evidence gained from the cases. Follow-up information 

was requested and discussions are on-going to gather more 

cases for submission, as well as ideas for future research 

collaboration.

In July 2010, Dr. Zia organized and presented the CAM 

section of the Division of Cancer Prevention’s Summer 

Curriculum in Cancer Prevention. This was a 4 week 

summer course that provided specialized instruction in the 

principles and practice of cancer prevention and control. 

The target audiences were physicians, research fellows, 

scientists, and other health care professionals from the 

United States as well as abroad, with an interest in the 

field. The CAM section was received well and overall 

highly rated by the participants.

CRISP is involved in an on-going collaboration with 

NCI’s Community Oncology and Prevention Trials 

Research Group of the Division of Cancer Prevention, 

which plays a role in all aspects of the design and 

implementation of NCI’s large cancer prevention and 

symptom management clinical trials. Dr. Zia participates 

in concept and protocol reviews of trials utilizing CAM 

approaches, providing medical oncology and CAM 

research expertise and guidance.
20 NCI CAM ANNUAL REPORT 2010

OCCAM Staff Publications in FY2010

In FY 2010 OCCAM Director Dr. Jeffrey D. White was 

published in the Journal of the National Cancer Institute

for his solo-authored editorial titled: “The challenge of 

rational development of complex natural products as 

cancer therapeutics.” 

The article is available in the National Library of 

Medicine’s PubMed medical literature database: 

http://www.ncbi.nlm.nih.gov/pubmed/20505150

OCCAM’s Participation at Major Professional 

Conferences (OCCAM staff attending)

•	 2009 International Cancer Education Conference, 

October 15-17, 2009, Houston, TX (Shea Buckman)

•	 American Public Health Association Annual 

Meeting, November 7-11, 2009, Philadelphia, PA 

(Elizabeth Austin, Shea Buckman, Dr. Isis Mikhail 

participated in a Meet-the-Expert Session)

•	 6th International Conference of the Society for 

Integrative Oncology, November 12-13, 2009, 

New York City, NY (Shea Buckman, Dr. Isis Mikhail, 

Dr. Dan Xi)

•	 Evidence-Based Complementary and Alternative 

Cancer Therapies Conference, January 7-9, 2010, 

West Palm Beach, FL (Shea Buckman, Dr. Farah Zia, 

Dr. Oluwadamilola Olaku)

•	 9th Annual Oxford International Conference on the 

Science of Botanicals, April 12-15, 2010, Oxford, 

MS (Dr. Jeffrey D. White gave a presentation titled 

“Botanicals Research and Cancer: What is needed for 

high-impact US clinical trials?”)

•	 101st American Association for Cancer Research 

Annual Meeting, April 17-21, 2010, Washington, 

DC (Drs. Jeffrey D. White, Libin Jia, Dan Xi, and 

Farah Zia)

•	 National Cancer Registrars Association 36th 

Annual Education Conference, April 20-23, 2010, 

Palm Springs, CA (Dr. Isis Mikhail gave an oral 

presentation titled “Use of Complementary and 

Alternative Medicines Among Cancer Patients in 

SEER”)

•	 Oncology Nursing Society 35th Annual Congress, 

May 13-16, 2010, San Diego, CA (CDR Colleen 

Lee presented a poster titled “Oncology Nursing 

Society, Special Interest Group, Complementary and 

Integrative Therapies”)
21 

•	 5th International Congress on Complementary and 

Alternative Medicine, May 19-21, 2010, Tromsø, 

Norway (Shea Buckman led a workshop titled 

“What are the Best Practices in the Development 

of Patient Education Materials” and gave an oral 

presentation titled “Cures, Conspiracy, and CAM: 

Common Myths of Cancer Patients;” Dr. Isis Mikhail 

presented a poster titled “NCI Cancer Centers 

Program and Integrative Medicine Programs in the 

United States”)

•	 The 17th International Symposium on Functional 

Medicine, May 20-23, 2010, Carlsbad, CA (Dr. 

Jeffrey D. White gave a presentation titled “The 

National Cancer Institute and Complementary and 

Alternative Medicine Research”)

•	 Medical Library Association Conference, May 

21-16, 2010, Washington, DC (Dr. Jeffrey D. 

White gave a presentation titled “Providing 

Quality Complementary and Alternative Medicine 

Information to Cancer Patients”)

•	 American Society of Clinical Oncology Annual 

Meeting 2010, June 4-8, 2010, Chicago, IL 

(Dr. Farah Zia participated in a Meet-the-Expert 

Session)

•	 Drug Information Association, 46th Annual 

Conference, June 15, 2010, Washington, D.C. 

(Dr. White gave a talk titled “The National Cancer 

Institute and Herbal and Dietary Supplement 

Research” and chaired a session titled “NIH Research 

and Development in Botanicals Including Dietary 

Supplements”)

•	 Meeting of the President’s Cancer Panel: America’s 

Demographic and Cultural Transformation – 

Implications for the Cancer Enterprise, Feb. 2, 2010 

Miami, FL (Dr. White gave a presentation titled 

“Complementary and Alternative Medicine and 

Cancer: Cultural and Demographic Perspectives”)

OCCAM Staff List: FY 2010

Jeffrey D. White, M.D. Director, OCCAM

Christina Armstrong Administrative Program Specialist

Akia Samuda Administrative Assistant

Isis Mikhail, M.D., Dr.P.H., M.P.H. Director, Extramural Research Program

Dan Xi, Ph.D. Program Officer, Extramural Research Program

Oluwadamilola Olaku, M.D., M.P.H. Scientific Program Analyst

Libin Jia, M.D. Health Scientist Administrator

Akiko Nakayama, M.S. Scientific Program Analyst

Farah Zeba Zia, M.D. Director, Case Review and Intramural Science Program

CDR (U.S. PHS) Colleen Lee, M.S., AOCN® Coordinator, Case Review and Intramural Science Program

Shea Buckman, M.A. Coordinator, Communications and Outreach Program

Elizabeth Austin, M.S. Communication Analyst, Communications and Outreach Program

Miriam Al-Keliddar, M.P.H. Cancer Research Training Award Fellow

Jeans Santana, B.A. Cancer Research Training Award Fellow

OFFICE OF CANCER COMPLEMENTARY AND ALTERNATIVE MEDICINE (OCCAM)
NCI CAM Communications Programs

22 NCI CAM ANNUAL REPORT 2010
NCI directs communications programs committed to providing current and 

credible information resources about CAM to its stakeholders.

23 NCI CAM COMMUNICATIONS PROGRAMS
24 NCI CAM ANNUAL REPORT 

Providing Information Online

OCCAM’s Web site (http://www.cancer.gov/cam) serves 

as NCI’s information hub on CAM issues. It provides 

a wealth of information resources and timely updates 

about the Institute’s CAM research portfolio, grant 

opportunities, and other news. 

Included on the OCCAM site are links to other 

information sources such as the Physician Data Query 

(PDQ®), which is NCI’s comprehensive cancer database. 

PDQ® produces summaries covering topics such as cancer 

treatment, prevention, screening, and CAM. 

Most Frequently Accessed PDQ®

CAM Summaries

NCI tracks the number of page views of each PDQ®

CAM summary on Cancer.gov within both the patient 

and health professional versions. The number of page 

views is determined by the number of views to the first 

page of each PDQ® summary. 

In FY 2010, the patient version summary with the 

highest number of page views was Coenzyme Q10, with 

44,792 page views. The next most frequently accessed 

patient summary was for Essiac/Flor Essence with 41,624. 

Third in the rankings was the Gerson Therapy summary 

with 33,791. 

During FY 2010, the highest number of page views 

received for a health professional version of a PDQ®

CAM summary was 18,062 for Aromatherapy and 

Essential Oils. The second most frequently accessed health 

professional version was the Mistletoe Extracts summary 

with 14,015. The Essiac/Flor Essence professional 

summary received the third most page views, with 

13,417. 

Figure 10 shows the total number of page views during 

FY 2010 for all of the PDQ® CAM summaries in both the 

patient and health professional versions. The complete list 

of PDQ® Complementary and Alternative Medicine 

Summaries can be viewed at http://www.cancer.gov/

cancertopics/pdq/cam.

NCI CAM Clinical Trials

The NCI Clinical Trials Registry, including CAM-related 

and non CAM-related trials, is available on the NCI Web 

site at http://www.cancer.gov/clinicaltrials/search/. This 

database includes approximately 11,000 abstracts of 

protocols that are open and approved to accept patients. 

Many CAM approaches are being studied via clinical 

trials in cancer patients. The OCCAM Web site hosts a 

database which organizes CAM clinical trials by cancer 

types and types of symptoms (http://www.cancer.gov/

cam/clinicaltrials_table.html). Clicking on an entry in the 

table triggers a search of the NCI’s Cancer Clinical Trials 

Registry. The table also archives trials that are currently 

closed.

In FY 2010, there were 90 NCI-supported cancer CAM 

clinical trials. (See Appendix for the complete list.) 

Note: NCI Web sites do not offer personalized medical advice to individuals 

about their condition or treatment, and the resources on the sites should not 

be used as a substitute for professional medical care.

Figure 10. PDQ® CAM Summaries FY10

Patient summary page views 

714X Acupuncture Antineoplastons Aromatherapy 

and Essentail Oils

Cancell/Cantron/Protocel Cartilage 

(Bovine and Shark)

Coenzyme Q10 Essiac/Flor-Essence Gerson Therapy

Totals 7283 17656 13811 19194 6616 10325 44792 41624 33791

Health professional summary page views

714X Acupuncture Antineoplastons Aromatherapy 

and Essentail Oils

Cancell/Cantron/Protocel Cartilage 

(Bovine and Shark)

Coenzyme Q10 Essiac/Flor-Essence Gerson Therapy

Totals 2481 12874 4444 18062 9872 6340 9946 13417 9457

2010
25 NCI CAM COMMUNICATIONS PROGRAMS

Producing Publications

In addition to the OCCAM Web site, various offices 

within NCI provide educational materials on CAM in 

print format to health professionals, people affected by 

cancer, and the general public.

NCI’s Annual Report on CAM 

OCCAM published NCI’s Annual Report on Complementary and Alternative Medicine: Fiscal Year 2009, 

which documented NCI’s participation in and support of 

a wide range of CAM activities. The report highlights the 

contributions of communications programs, training and 

conferences, and cancer CAM research in addressing the 

NCI strategic areas to support the elimination of suffering 

and death due to cancer. 

The report can be viewed and downloaded from: http://

www.cancer.gov/cam/attachments/nci_cam_annual_

report_fy09.pdf

Newsletter on NCI’s CAM Activities

OCCAM’s twice-yearly newsletter, NCI CAM News, 

provides the latest information on NCI-sponsored research, 

funding opportunities, meetings and workshops, as 

well as educational information on cancer and CAM. 

NCI CAM News also includes features on cancer CAM 

projects representing the full range of NCI’s activities as 

well as OCCAM program updates. 

The following issues of NCI CAM News were made 

available online in FY 2010:

•	 Spring 2010 http://www.cancer.gov/cam/

newsletter/2010-spring/spring2010_OCCAM_

newsletter_home.html

•	 Fall 2010 http://www.cancer.gov/cam/

newsletter/2010-fall/fall2010_OCCAM_newsletter_

home.html

NCI CAM News is available via email by subscribing 

online at https://list.nih.gov/cgi-bin/wa.exe?SUBED1=

NCI_CAM_NEWS&A=1

Patient summary page views 

Gonzalez Regimen Hydrazine Sulfate Laetrile/Amygdalin Milk Thistle Mistletoe Extracts Newcastle 

Disease Virus

PC-SPES Selected Vegetables/ 

Sun’s Soup

Spirituality in Cancer 

Care

5757 9584 29104 25706 22502 4955 5080 8090 12987

Health professional summary page views

Gonzalez Regimen Hydrazine Sulfate Laetrile/Amygdalin Milk Thistle Mistletoe Extracts Newcastle 

Disease Virus

PC-SPES Selected Vegetables/ 

Sun’s Soup

Spirituality in 

Cancer Care

3585 1686 6793 8881 14015 3195 4022 4749 8519
26 NCI CAM ANNUAL REPORT 2010

CAM in NCI Newsletters and Publications

The NCI Cancer Bulletin (http://www.cancer.gov/

ncicancerbulletin) is a biweekly online newsletter designed 

to provide useful, timely information about cancer 

research to the cancer research community. During 

FY 2010, several cancer CAM studies were featured in 

the NCI Cancer Bulletin:

•	 Antioxidant Supplement May Prevent Return of 

Precancerous Colorectal Growths (http://www.cancer.

gov/aboutnci/ncicancerbulletin/archive/2009/121509/

page3#e), December 15, 2009 

•	 Adapting the Science of Supplements and Cancer 

Prevention (http://www.cancer.gov/aboutnci/nci

cancerbulletin/archive/2009/121509/page6), 

December 15, 2009 

•	 Acupuncture Reduces Joint Pain in Some Women 

with Breast Cancer (http://www.cancer.gov/aboutnci/

ncicancerbulletin/archive/2010/012610/page3#d),

January 26, 2010 

•	 Fatigue: Is it Normal or Pathological? And How 

Can We Best Treat It? (http://www.cancer.gov/

ncicancerbulletin/032310/page5), March 23, 2010

•	 Complementary and Alternative Medicine 

Commonly Used by Pediatric Patients

(http://www.cancer.gov/ncicancerbulletin/040610/

page3#c), April 6, 2010

•	 Shark Cartilage Extract Ineffective Against 

Lung Cancer (http://www.cancer.gov/

ncicancerbulletin/060110/page3#d), June 1, 2010

•	 Vitamin D Concentrations in Blood Not Linked to 

Risk of Less Common Cancers (http://www.cancer.

gov/ncicancerbulletin/062910/page3#d), June 29, 

2010

•	 Guidelines Urge Exercise for Cancer 

Patients, Survivors (http://www.cancer.gov/

ncicancerbulletin/062910/page5), June 29, 2010

•	 Consuming High Levels of Red Meat and Fat 

May Increase Liver Cancer Risk (http://www.cancer.

gov/ncicancerbulletin/090710/page3#e), 

September 7, 2010

NCI Fact Sheets on CAM

The NCI fact sheet collection addresses a variety of 

cancer topics, including cancer CAM. The fact sheets are 

frequently updated and revised based on the latest cancer 

research.

See the table on the next page for the list of the current 

nine NCI CAM fact sheets and the number of page views 

each fact sheet received during FY 2010. The NCI fact 

sheets collection can be found at http://www.cancer.gov/

cancertopics/factsheet.

The NCI Fact Sheet “Thinking About 

Complementary and Alternative Medicine: 

A Guide for People with Cancer” was 

viewed 22,462 times in FY 2010. To view this 

publication, please visit http://www.cancer.gov/

cancertopics/factsheet/therapy/cam.
27 NCI CAM COMMUNICATIONS PROGRAMS

Table 1: NCI CAM FACT SHEETS PAGE VIEWS STATISTICS FY 2010

Fact Sheet Title Total Views

Antioxidants and Cancer Prevention: Fact Sheet 83,669

Calcium and Cancer Prevention: Strengths and 

Limits of the Evidence 9,503

Garlic and Cancer Prevention: Questions and Answers 20,268

Physical Activity and Cancer: Fact Sheet 17,017

Questions and Answers About Beta Carotene 

Chemoprevention Trials 373

Red Wine and Cancer Prevention: Fact Sheet 13,985

Tea and Cancer Prevention: Fact Sheet 20,217

Vitamin D and Cancer Prevention: Strengths and 

Limits of the Evidence (New) 39,769

Thinking About Complementary and Alternative Medicine: 

A Guide for People with Cancer 22,462

Responding to CAM Cancer Inquiries

The Cancer Information Service (CIS) serves as NCI’s 

link to the public by interpreting and explaining 

research findings in a clear and understandable manner and providing personalized responses to specific 

questions about cancer. Highly trained cancer information specialists are available to answer questions 

via phone, live online chat, mail, and e-mail about 

cancer treatment and clinical trials, including CAM 

therapies. During FY 2010, CIS responded to 1,135 

inquiries regarding CAM approaches for cancer.

Access the CIS by calling 1-800-4-CANCER 

(1-800-422-6237), or by using the LiveHelp 

instant-messaging service at https://cissecure.nci.nih.

gov/livehelp/welcome.asp
28 NCI CAM ANNUAL REPORT 2010

Training and Conferences
NCI provides a variety of training-support programs on different aspects of 

CAM research including grant writing workshops and scientific conference 

sponsorships.

29 TRAINING AND CONFERENCES
Training Opportunities at OCCAM

During FY 2010, OCCAM hosted two Cancer Research 

Award Training (CRTA) Fellows, Jeans Santana and 

Miriam Al-Keliddar who worked with the Case Review 

and Intramural Science Program and the Extramural 

Research Program, respectively. Mr. Santana’s work 

included writing a manuscript analyzing cancer CAM 

use among Hispanics in the United States and reviewing 

case reports for the NCI Best Case Series Protocol. 

Ms. Al-Keliddar worked on two manuscripts about 

prostate cancer and herbs, and canine cancer models.

NCI Lectures and Workshops on CAM

NCI provides educational opportunities for its staff, 

fellows, and the public on topics related to cancer. 

In FY 2010, the following seminars and lectures relevant 

to CAM research were held at NCI: 

•	 3rd Congress of the International Society of 

Nutrigenetics/Nutrigenomics 

(Division of Cancer Prevention, NCI) 

October 21-23, 2009

•	 Soliciting Nature’s Help for Prevention of Cancer

(Frederick Cancer Research Facility, NCI) 

November 4, 2009

•	 Dietary Chemopreventive Agents – Findings from 

Shanghai and Singapore Cohort Studies 

(Epidemiology and Genetics Research Program, NCI) 

March 15, 2010

•	 Natural Products: Keys to Treating Cancer and 

Infection 

(Office of the Director, NIH) 

March 16, 2010

•	 Can we Prevent Breast Cancer Using Natural 

Compounds? 

(Division of Cancer Prevention, NCI) 

June 4, 2010

CAM Monthly Lecture Series at NCI

The OCCAM Monthly Lecture Series informs the NCI 

community about recent and ongoing research projects in 

cancer CAM. These hour-long lectures feature a 50 minute 

presentation on a cancer CAM topic and allow 10 minutes 

for questions. The lectures are open to the public and are 

archived as videocasts on the OCCAM Web site at http://

www.cancer.gov/cam/news_lectures.html

In FY 2010 the following lectures were presented as part 

of the OCCAM Monthly Lecture Series: 

•	 Inhibition of the Anti-apoptotic Activity of 

Galectin-3 with GCS-100, a Citrus Pectin Derivative 

in B-cell Lymphoma

•	 Melatonin via the MT1 Receptor and the Circadian 

Clock Suppresses the Initiation, Promotion, and 

Progression of Breast Cancer

•	 Solubility and Permeability Enhancement by 

New Nano-micellar Natural Compounds

•	 Prostate Cancer Prevention by Soy: Pitfalls and 

Opportunities

•	 Clinical and Biologic Effects of Curcumin in 

Multiple Myeloma

•	 Head and Neck Cancer Chemoprevention: 

Intervention Using Local Delivery Strategies

•	 MR Visible Changes in Prostate Cancer Choline 

Metabolism: Response to Soy-based Dietary 

Interventions that Inhibit Tumor Growth

•	 Therapeutic Effects of Boswellia Extracts and Pure 

Components in Prostate Cancer and Leukemia

•	 Curcumin/TRAIL Combination Therapy for 

Prostate Cancer 

•	 Acupuncture and Cancer Pain

30 NCI CAM ANNUAL REPORT 2010
SUPPORTING SCIENTIFIC CONFERENCES

In FY 2010, NCI supported the following conferences that included CAM 

content:

• American Psychosocial Oncology 

Society Annual Conference: 

Integrating Psychosocial 

Research and Practice in 

Quality Cancer Care 

February 18-21, 2010 

New Orleans, LA 

Grant number: 5R13CA138133-02

• 2010 Marine Natural Products: 

Gordon Research Conferences 

February 28-March 5, 2010 

Ventura, CA 

Grant number: 1R13CA144320-01

• Society of Behavioral Medicine 

50th Annual Meeting 

April 27-30, 2010 

Washington, DC 

Grant number: 5R13CA091918-10

• 2010 Federation of American 

Societies Experimental Biology 

Conference on Retinoids 

June 13-18, 2010 

Carefree, AZ 

Grant number: 1R13DK088433-01

• 2010 Metals in Medicine: Gordon 

Research Conferences 

June 27-July 2, 2010 

Andover, NH 

Grant number: 1R13GM093354-01

• 11th International Congress of 

Behavioral Medicine (ICBM2010) 

August 4-7, 2010 

Washington, DC 

Grant number: 1R13CA144430-01

• International Symposium on Breast 

Cancer Prevention: Nutrition, 

Communication, and Public Policy 

October 18-19, 2010 

West Lafayette, IN 

Grant number: 1R13CA153904-01

• American Society of 

Pharmacognosy 

51st Annual Meeting 

July 30-August 3, 2011 

San Diego, CA 

Grant number: 5R13CA139768-02

31 TRAINING AND CONFERENCES
HIGHLIGHTS FROM 

NCI’s CAM Training Projects

32 NCI CAM ANNUAL REPORT 2010
The highlights on the following pages are selected from the 27 CAM training 

projects that NCI supported during FY 2010 at laboratories and clinics 

throughout the United States and the world. NCI’s programs allow students 

and professionals at all stages of their careers to develop the skills necessary 

to conduct basic, clinical, and cancer control research into CAM therapies and 

interventions.

Abstracts of projects featured in this report can be found by searching 

the grant or project number the NIH RePORTer research trials database at 

http://projectreporter.nih.gov/reporter.cfm.

33 HIGHLIGHTS FROM NCI’S CAM TRAINING PROJECTS
34 NCI CAM ANNUAL REPORT 

H i g h l i g h t s f r o m 

N C I ’s C A M 

Training Projects

2010

Center for 

Cancer Training

Exercise Researcher Refocuses Career on 

Cancer Prevention and Control Studies

L

ynette Craft, Ph.D., is a kinesiologist 

who began her scientific career studying 

the use of exercise to improve symptoms 

in patients with clinical depression. 

However, while pursuing her postdoctoral work at Boston University she had the 

opportunity to work on an NCI-funded research 

study “in which we were primarily looking at 

physical health outcomes related to exercise 

involvement with breast cancer patients,” 

she recalled. “I became very interested in the 

mental health outcomes that might also result 

from breast cancer survivors participating in 

exercise programs.” 

Now an Assistant Professor of Preventive 

Medicine at Northwestern University School of 

Medicine, Dr. Craft is using an NCI Mentored 

Career Development Award* to shift gears and 

refocus her research into the growing field of 

exercise and cancer prevention and care. “It will 

allow me the time I need to initiate this new 

line of research and to develop collaborative 

relationships with other investigators who are 

doing similar types of work and move forward 

in my career,” she noted.

Dr. Craft is currently using the career award to 

conduct a pilot randomized controlled trial to 

explore the feasibility and effectiveness of an 

intermittent exercise intervention in women 

with early stage breast cancer who are at 

least 6 months post adjuvant treatment. This 

intermittent-exercise group will be compared to 

a standard exercise intervention and a usual care 

control group, to determine which intervention 

can most effectively alleviate cancer-related 

symptoms (depression, pain, and fatigue) and 

positively impact biomarkers of metabolic 

function.

“We know that, physiologically, the accumulation of exercise through shorter bouts 

(15 minutes each) generates the same kind of 

physical health outcomes as does one longer 

bout of 30 minutes,” Dr. Craft said. “However, 

we don’t really know whether the effects of two 

small bouts of exercise will be the same as one 

longer session on relieving pain, depression, and 

fatigue. That’s one thing we’re looking at: Will 

we find equivalent effects on those outcomes?” 

The study will also examine exercise adherence 

rates because if breast cancer patients “are experiencing pain, fatigue, and depression, they may 

find it easier to do shorter bouts of exercise than 

to do 30 minutes all at once,” she added. 

Dr. Craft has assembled an “A-team” of comentors at Northwestern University and its 

NCI-designated Cancer Center and elsewhere 

who are helping her with this cancer exercise study. “When I came to Northwestern 

University, the Cancer Center here was very 

excited about having someone who could do 

exercise-related research,” she recalled. Her 

team includes a cancer epidemiologist, a clinical 

psychologist and behavioral medicine expert, an 

expert in quality of life measurement in cancer 

patients, a breast surgeon, and an expert in 

developing exercise interventions with cancer 

survivors. These experienced researchers will 

guide Dr. Craft’s progress, provide supervision, 

and support the activities outlined in her career 

development plan. 

Dr. Craft said, “I hope to continue my career 

along this path of cancer survivor research. I see 

exercise and mental health as an important area 

that can benefit all types of cancer survivors, 

not just breast cancer patients. There are several 

other types of cancer, like head and neck cancer 

or prostate cancer, whose survivors experience 

high rates of depression but have not been 

extensively studied with respect to exercise 

interventions.” 

Another group of people who have not received 

much attention in the exercise literature are 

adolescent and young adult cancer survivors. 

“Often they have higher levels of distress, for 

some of the same, but also for different, reasons 

than older patients,” Dr. Craft commented. 

“We know that lifestyle issues like being overweight and obesity are starting younger and 

younger, so that might be an interesting group 

to look at with respect to how exercise affects 

their mental health, as well as how exercise 

affects physical health outcomes.”

*Grant number: 

 5K07CA134936-02
35 

H i g h l i g h t s f r o m 

N C I ’s C A M 

Training Projects

HIGHLIGHTS FROM NCI’S CAM TRAINING PROJECTS

Center to Reduce 

Cancer Health 

Disparities

Curcumin Investigated to Prevent 

Prostate Cancer Metastasis

P

rostate cancer claims the lives of about 

30,000 men each year in the United 

States. Those deaths are due almost entirely to metastasis, or spread of the cancer to other organs. Approximately 75% 

of men with early-stage prostate cancer can be 

successfully treated with surgery and will not 

have a recurrence of their disease. Oncologists, 

however, currently lack the ability to accurately 

distinguish the remaining 25% of patients at 

high risk for recurrence who would benefit from 

adjuvant, or additional, therapy after surgery.” 

A recent study* identified a trio of substances 

known as chemokines (small proteins secreted 

by cells) found in prostate tissue that accurately 

predicted whether prostate cancer would recur 

within five years of surgery. When prostate 

tissue contained abnormally high amounts of 

two of these substances, known as CX3CL1 and 

IL-15, the cancer was highly unlikely to recur 

within that period. By contrast, when tissue 

contained abnormally high amounts of the 

third identified chemokine, CCL4, recurrence 

was likely. 

Magaly Martinez-Ferrer, Ph.D., of the University of Puerto Rico Comprehensive Cancer Center 

(UPRCCC) – one of the researchers who participated in the study – is now trying to extend 

these findings by determining whether this 

trio of chemokines can affect prostate cancer 

metastasis. In addition, with NCI funding in 

the form of a Continuing Umbrella of Research 

Experience (CURE) K01 diversity training 

grant**, she is examining whether treatment 

with curcumin, a chemical component of the 

spice turmeric, can promote or inhibit metastasis by modifying the levels of these chemokines 

in prostate tissue.

Curcumin has previously been shown to inhibit 

colon tumors and, in some studies, has been 

associated with a reduction in the size of 

prostate tumors, according to Dr. MartinezFerrer. Other studies have found that curcumin 

has anti-inflammatory properties, although the 

mechanism for this is unclear. Previous research 

also suggests that chronic inflammation may 

promote prostate cancer metastasis. A randomized, double-blind, placebo-controlled clinical trial is currently under way at UPRCCC 

to determine whether curcumin can shrink 

precancerous growths in patients with a genetic 

disorder that puts them at an extremely high 

risk for colorectal cancer.

At the 2011 American Association for 

Cancer Research annual scientific meeting, 

Dr. Martinez-Ferrer reported the initial results 

of experiments in which CX3CL1 and IL-15 

chemokines were added to a highly metastatic 

prostate cancer cell line.*** The addition of the 

chemokines significantly decreased proliferation 

and migration of the cells, suggesting that they 

may suppress metastasis. 

Dr. Martinez-Ferrer plans to investigate 

whether treatment with curcumin modifies 

metastasis, tumor size, or inflammation in 

both cell lines to which CX3CL1 and IL-15, or 

CCL4 have been added, or in laboratory mice 

implanted with prostate tumors. 

She hopes this work will ultimately show that 

these three chemokines can either promote or 

inhibit prostate cancer metastasis and, further, 

that treatment with curcumin can modify these 

effects by altering levels of these chemokines 

in prostate cancer cells or in laboratory mice. 

If that proves to be the case, the next step, 

according to Dr. Martinez-Ferrer, would be to 

conduct a clinical trial in which patients at risk 

for prostate cancer recurrence would be treated 

with curcumin to determine whether this intervention reduces the risk of disease metastasis. 

*Blum DL, Koyuama T, M’Koma AE, et al. Chemokine markers predict biochemical recurrence of prostate cancer following 

prostatectomy. Clinical Cancer Research, 2008; 14(23): 7790-7

**Grant number: 

7K01CA140711-02 ***Martinez-Ferrer M, Qi Y, Sanchez MM, Bhowmick NA. Inflammatory mediators of prostate cancer metastasis. Abstract #391, 

presented at American Association for Cancer Research 102nd Annual Meeting; April 3, 2011; Orlando, FL.
HIGHLIGHTS FROM

NCI’s CAM Research

36 NCI CAM ANNUAL REPORT 2010
Understanding the Causes and Mechanisms 

of Cancer

Cancer is a complex set of diseases that scientists are striving to understand 

from multiple perspectives. Research that improves our understanding of its 

causes and the mechanisms that underlie its development – from assessing 

cancer risk to explaining the process of metastasis – is essential to our ability to 

develop and apply interventions to preempt cancer initiation and progression.

37 UNDERSTANDING THE CAUSES AND MECHANISMS OF CANCER
38 NCI CAM ANNUAL REPORT 

U n d e r s t a n d i n g 

t h e C a u s e s a n d 

M e c h a n i s m s o f 

Cancer

2010 

Division of Cancer 

Treatment and 

Diagnosis

Compound in Red Sage Plant May Help 

Control Blood Vessels that Feed Tumors

A

mong the most widely used plants 

in traditional Chinese medicine 

(TCM) is red sage, known in China 

as Danshen (Salvia miltiorrhiza). It 

stimulates blood flow and is used to 

treat inflammation, cardiovascular disease, and 

cerebrovascular disease. According to TCM 

principles, cancer is a form of tissue swelling, 

and thus using substances that stimulate blood 

flow may help treat many types of cancer. 

But there is a paradox at work here, said Bin 

Chen, Ph.D., who was trained in TCM and 

pharmacology at Nanjing University of Chinese 

Medicine in China. “Cancers also make use of 

the circulatory system by growing blood vessels 

into a pipeline that delivers oxygen and nutrients to nourish and extend tumors.”

It is therefore common in the West to treat 

some tumors with antiangiogenic therapy, 

using drugs that prevent new blood vessels 

from growing. Dr. Chen’s research focuses on 

vascular-disrupting therapy, because he is not 

only interested in preventing new blood vessels 

from forming but is also seeking to destroy 

the existing blood vessels within the cancerous 

tissue.

With NCI funding*, his laboratory at the 

University of the Sciences in Philadelphia is 

conducting a pilot study of how tanshinone 

IIA (Tan IIA), one of Danshen’s active 

ingredients, might become a key piece in 

vascular-disrupting therapy. In previous 

laboratory studies on cancerous endothelial 

cells that line blood vessels, Tan IIA was able 

to attack and kill cells in several different ways. 

What hasn’t been studied is exactly how these 

effects might be marshaled to target the blood 

pipelines that can feed tumors throughout 

the body.

Dr. Chen and his colleagues will try to fill in 

the important details about how Tan IIA works 

against prostate cancer by experimenting on 

mice that have been implanted with human 

tumor cells. “We give the Tan IIA compound 

to the mice, and with a special imaging system 

we can watch to see if blood vessels grow or 

not,” he said. “If the impact is evident shortly 

after treatment begins, the Tan IIA is probably 

disrupting the blood vessels that are already 

in place.” 

However, if new blood vessels do not develop 

in the mice, then the Tan IIA is behaving more 

like an antiangiogenic drug by denying the 

tumor the new blood supply that it needs to 

grow, Dr. Chen added. This effect on the tumor 

growth is evident only over time, because it 

targets the endothelial cells that are necessary 

for new blood vessels to grow.

“Our longstanding interest in how the vascular 

system affects cancer encouraged us to look 

at whether Tan IIA might be used to control 

blood flow in ways that we could exploit,” 

Dr. Chen explained. Because most cancer 

cell-killing chemotherapeutic drugs used in 

the West travel in the bloodstream, this work 

will also focus on whether Tan IIA can help 

deliver such drugs more effectively to the site 

of the tumor, Dr. Chen added.

He is also testing whether Tan IIA could be 

used to improve the delivery of other anticancer 

agents. “Tumors in the prostate and elsewhere 

survive in part by developing defenses against 

our drug therapies,” he explained. “For 

example, the tumors’ blood vessels are not 

efficient for the delivery of chemotherapy 

drugs circulating in the bloodstream.” 

“Because Tan IIA is so safe and essentially has 

no side effects, we can deliver it chronically 

and in large amounts,” Dr. Chen said. The goal 

would be to change the permeability of tumor 

vessels to allow more of the accompanying 

chemotherapy drug to reach the tumors. The 

basic challenge with chemotherapy drugs is 

how toxic they can be to other parts of the 

body beside the tumor, he noted. If the Tan 

IIA allows more of the cancer drug to reach the 

tumor, then less of the drug overall would be 

needed, and thus other side effects could 

be reduced.

*Grant number: 

 5R21CA150277-02
39 UNDERSTANDING THE CAUSES AND MECHANISMS OF CANCER
40 NCI CAM ANNUAL REPORT 

U n d e r s t a n d i n g 

t h e C a u s e s a n d 

M e c h a n i s m s o f 

Cancer

2010

Center for 

Cancer Research

Scientists Study Biomarkers of High-Fiber 

Diets to Lower Risk of Colorectal Cancer 

C

olorectal cancer (CRC) is the third 

leading cause of cancer death among 

both men and women in the United 

States. Screening for CRC can both 

reduce the death rate from this disease 

and prevent it by detecting and removing precancerous growths known as adenomatous polyps. Yet despite its demonstrated effectiveness, 

most Americans over age 50 – the group most 

at risk for CRC – do not undergo screening. 

NCI’s Polyp Prevention Trial (PPT) was a 

4-year randomized trial designed to determine 

the effect of a low-fat, high-fiber diet high in 

fruit and vegetables on polyp recurrence. Study 

participants included more than 2,000 people 

at high risk for CRC because of a history of 

polyps. Participants were randomly assigned to 

follow either their usual diet or the diet high 

in fruits and vegetables. Although the trial 

results showed no overall difference in adenoma 

recurrence between the two groups, closer 

analysis found a substantial decrease in recurrence among the 25% of participants who most 

consistently adhered to the diet high in fruits 

and vegetables*.

For example, the 25% of PPT participants who 

consumed the largest quantities of beans had 

a three-fold reduced risk of adenoma recurrence compared with the 25% of participants 

who consumed the lowest quantities. Beans, or 

legumes, are rich in fiber and soluble substances 

with anti-inflammatory and anticancer effects. And the 25% of PPT participants who 

consumed the most flavonols – substances 

abundant in foods such as beans, onions, apples, 

and tea – had a 76% decreased risk of adenoma 

recurrence. 

Other studies have suggested that insulin resistance and low-level chronic inflammation may 

act together to promote CRC and that a highfiber diet may influence blood levels of both 

C-peptide, an established biomarker for insulin 

resistance, and C-reactive protein (CRP), an 

established biomarker for inflammation.

Building on these findings, researchers from 

NCI’s Center for Cancer Research, Pennsylvania State University (PSU), and Texas A & M 

University designed a study to compare the 

effects of a high-bean diet or a healthy, low-fat 

control diet on these biomarkers in men at risk 

for CRC**. Half of the 64 men in the study – 

known as the Legume Inflammation Feeding 

Experiment (LIFE) – had a history of polyp 

removal and half did not***. 

“We have learned from the PPT and other studies that not everybody is going to benefit from 

a particular dietary intervention,” said Nancy 

H. Colburn, Ph.D., chief of NCI’s Laboratory of 

Cancer Prevention, who has played a leadership 

role in both the PPT follow-up studies and the 

LIFE study, along with Elaine Lanza, Ph.D., 

who led the PPT while at NCI, and Terryl 

Hartman, Ph.D., of PSU. “But we have also 

learned that subgroups of people can benefit.” 

The men in LIFE were randomly assigned to 

spend 4 weeks on one of the two study diets, 

followed by a 3-week break, followed by 4 

weeks on the other study diet. The diets were 

designed to maintain the men’s existing weight. 

Blood concentrations of CRP declined by 20% 

while the men were on the high-bean diet and 

by about 18% while they were on the control 

diet. A trend was seen toward reduced blood 

concentrations of C-peptide on the high-bean 

diet. In preliminary results using a novel 

method that isolates RNA from patients’ fecal 

stools, researchers identified sets of gene expression changes after 4 weeks on the high-bean 

diet that may predict a reduced risk for polyp 

recurrence. 

**Project number: 

ZIA BC 011159
41 

Meanwhile, further analyses of the PPT have 

identified two potential biomarkers for adenoma recurrence. PPT participants with elevated 

blood levels of homocysteine – an amino acid 

that can promote inflammation, tissue damage, 

cardiovascular disease, and cancer – had a twofold increased risk of adenoma recurrence. And 

the greatest reduction in risk for recurrence of 

high-risk and advanced adenomas (those most 

likely to become cancerous) was seen in participants who consumed the most flavonols and 

had decreased blood concentrations of IL-6, a 

substance that promotes inflammation and may 

promote growth of colorectal tumors. 

Dr. Colburn noted that the goal of the postPPT studies “is to personalize dietary interventions to prevent CRC by matching them with 

the groups of people most likely to benefit. 

To achieve that goal, we need biomarkers that 

accurately identify those most likely to benefit 

from an intervention and that can be measured 

noninvasively by means of a simple blood or 

stool test.”

* Lanza E, Hartman TJ, Albert PS, Shields R, Slattery M, Caan B, Paskett E, Iber F, Kikendall JW, Lance P, Daston C, Schatzkin 

A. High dry bean intake and reduced risk of advanced colorectal adenoma recurrence among participants in the polyp 

prevention trial. The Journal of Nutrition. 2006 Jul;136(7):1896-903.

*** Hartman TJ, Albert PS, Zhang Z, Bagshaw D, Kris-Etherton PM, Ulbrecht J, Miller CK, Bobe G, Colburn NH, Lanza 

E. Consumption of a legume-enriched, low-glycemic index diet is associated with biomarkers of insulin resistance and 

inflammation among men at risk for colorectal cancer. The Journal of Nutrition, 2010 Jan;140(1):60-7.

UNDERSTANDING THE CAUSES AND MECHANISMS OF CANCER
42 NCI CAM ANNUAL REPORT 2010

U n d e r s t a n d i n g 

t h e C a u s e s a n d 

M e c h a n i s m s o f 

Cancer

Division of 

Cancer Biology

Researchers Study Whether Altering 

Cellular Fats Raises Cancer Risk

O

xygen, while necessary for life, can also 

damage molecules inside our bodies 

due to its highly reactive nature. 

Oxygen can “pull” electrons from 

many other molecules in the body 

through a process called oxidation, causing 

them to be reactive and unstable. If these 

reactive molecules interact with DNA, the 

result can be DNA damage, which is an early 

step in carcinogenesis (cancer formation). The 

fatty acids widespread in the body, including 

those found on the membranes of cells, are 

vulnerable to a type of oxidative damage called 

lipid peroxidation. Fung-Lung Chung, Ph.D., 

professor of oncology at Georgetown University 

Medical Center, is interested in how DNA 

damage, driven by lipid peroxidation, may 

contribute to cancer formation. 

Previous research from his laboratory has 

shown* that the oxidation of polyunsaturated 

fatty acids found on cellular membranes can 

cause a type of DNA damage called a “cyclic 

adduct,” where a reactive compound formed by 

lipid peroxidation attaches itself to the doublehelix structure of DNA. These cyclic adducts 

have been found in animals, in humans, and 

even in cultured cells. However, whether cyclic 

adducts contribute to cancer formation – and if 

so, how – remains unclear.

“There’s a lot of talk in the literature about 

cancer risk related to fat intake—for example, 

a fatty liver is a risk factor for liver cancer,” 

explained Dr. Chung. “And a high-fat diet is 

associated with colon cancer. So we thought 

there might be some sort of mechanistic role 

for this type of DNA modification caused by 

fatty acid peroxidation in those cancers.” In his 

current research funded by NCI**, Dr. Chung 

and his colleagues are using two animal models 

with spontaneous liver cancer to better understand this process. One model, the Long Evans 

Cinnamon rat, accumulates abnormal levels of 

copper in the liver and subsequently shows an 

increase in lipid peroxidation and liver cancer. 

The second model is a mouse strain that lacks 

the DNA-repair mechanism, called nucleotide 

excision repair, that the body normally uses to 

repair cyclic adducts caused by lipid peroxidation. These mice also have a high incidence of 

spontaneous liver cancer.

The researchers will look at the relationships 

between accumulation of cyclic adducts in the 

liver and progressive stages of liver carcinogenesis. Researchers will also closely examine 

cyclic adduct binding to the p53 gene and the 

relationship between adduct binding and other 

p53 mutations found in liver tumors from these 

animals. The p53 gene is a known tumorsuppressor gene that is inactivated (“turned 

off”) by mutations in many types of cancer that 

contributes to runaway tumor-cell growth. 

In addition, Dr. Chung plans to test several 

antioxidants, including a mixture of green tea 

polyphenols (Polyphenon E) and dihydrolipoic 

acid (DHLA), to see if adding these compounds 

to the animals’ diets slows or prevents cyclic 

adduct formation. In a study published in 

2010***, Dr. Chung and his colleagues found 

that epigallocatechin gallate E, a green tea 

polyphenol, and DHLA inhibited the formation of cyclic DNA adducts in laboratory model 

systems.

* Chung FL, Chen HJ, Nath RG. Lipid peroxidation as a potential endogenous source for the formation of exocyclic DNA adducts. 

Carcinogenesis, October 1996;17(10):2105-11.

**Grant number: 

5R01CA134892-02

*** Nath RG, Wu MY, Emami A, Chung FL. Effects of epigallocatechin gallate, L-ascorbic acid, alpha-tocopherol, and dihydrolipoic 

acid on the formation of deoxyguanosine adducts derived from lipid peroxidation. Nutrition and Cancer, 2010;62(5):622-9.
43 

U n d e r s t a n d i n g 

t h e C a u s e s a n d 

M e c h a n i s m s o f 

UNDERSTANDING THE CAUSES AND MECHANISMS OF CANCER

Cancer

Division of Cancer 

Epidemiology and 

Genetics

Milk Thistle Extract Evaluated Against 

Cancer-Causing Liver Disease

C

hronic hepatitis C is a devastating disease that can lead to a variety of other 

illnesses including liver cancer. Available therapies don’t work for everyone 

and can have many adverse side effects. 

As a result, many people with chronic hepatitis C turn to CAM remedies, such as herbal 

products, noted Neal Freedman, Ph.D., M.P.H., 

of NCI’s Division of Cancer Epidemiology and 

Genetics (DCEG). 

One of the herbal products used most commonly by people with chronic liver disease 

is silymarin, which is an extract of the milk 

thistle plant Silybum marianum. Silymarin has 

been used to treat liver disease since the time of 

the ancient Greeks. However, few studies have 

rigorously tested the effectiveness of this herbal 

ingredient for chronic liver disease, and results 

from previous studies are inconsistent, Dr. 

Freedman added.

As part of a large, NIH-supported clinical trial 

known as the Hepatitis C Antiviral Long-Term 

Treatment Against Cirrhosis (HALT-C) study*, 

NIH investigators asked patients about their 

use of CAM treatments, including silymarin. 

The HALT-C trial was designed primarily to 

test the effectiveness of long-term treatment of 

hepatitis C with low doses of the drug peginterferon-alpha for patients who had not responded 

to previous standard-of-care therapy. At the 

outset of the study, investigators found that approximately one-third (34 percent) of patients 

in the trial reported that they had used silymarin, and half of those patients were current users 

of this herbal remedy, Dr. Freedman reported.

“When we learned that silymarin use was part 

of the information collected in HALT-C, we 

thought we should examine the possible effects 

of silymarin use on liver disease progression, 

as these results could contribute to the larger 

scientific understanding of the role of silymarin 

in liver disease,” Dr. Freedman commented.

Dr. Freedman and his colleagues in DCEG 

studied 1,049 patients in the HALT-C trial and 

compared clinical outcomes for current users of 

silymarin, against outcomes for patients who 

reported former silymarin use, and patients 

who said they had never used silymarin. The 

researchers looked at two outcomes for the 

three groups of patients: 1) progression of liver 

fibrosis, which was assessed by examining liver 

biopsies over the course of the study; and 2) 

liver-related clinical outcomes, which included 

liver cancer (hepatocellular carcinoma), ascites 

(accumulation of fluid in the abdominal cavity), 

variceal hemorrhage (rupturing of the veins in 

the esophagus), or liver disease-related death.

“Fibrosis is the term used when some of the 

liver tissue has been destroyed and replaced 

by scar tissue, and cirrhosis is where most of 

the liver has been destroyed,” explained Dr. 

Freedman. “As liver disease gets worse, patients 

progress from fibrosis to cirrhosis, and at each 

step their risk of liver cancer and other adverse 

clinical outcomes is much higher.”

Dr. Freedman reported that patients in the 

HALT-C trial who were currently taking 

silymarin were less likely to progress from 

fibrosis to cirrhosis**. “However, there was no 

association between silymarin use and clinical 

outcomes, and we’re not clear why that’s the 

case,” he added. It could be that the follow-up 

period for the current study was too short to 

see an effect of silymarin on clinical outcomes 

or to determine whether silymarin affects the 

progression of fibrosis but not other aspects of 

chronic liver disease, he suggested.

Dr. Freedman noted that the main limitation of 

the study was that investigators lacked information on how much silymarin each patient used. 

“Also, as an observational study, patients using 

silymarin may be different from patients who 

are not users of the herbal remedy. For example, 

they may have a different stage of disease, or 

silymarin use may be a proxy for another ‘habit’ 

that has an effect,” Dr. Freedman said. 

“Our results suggest that there might be an association between silymarin use and progression 

of liver disease, and future studies should look 

at this further,” he continued. “But, by itself, 

our study isn’t definitive and I think many 

more studies need to be done.” Future studies 

should assess exactly how much silymarin each 

patient is using, Dr. Freedman said, and ideally 

should compare patients who are randomly assigned to take a specific dose of silymarin with 

patients not receiving any silymarin.

*Grant number: 

Z01 CP005782

**Freedman ND, Curto TM, Morishima C, Seeff LB, Goodman ZD, Wright EC, Sinha R, Everhart JE, HALT-C Trial Group. 

Silymarin use and liver disease progression in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis trial. Alimentary 

Pharmacology and Therapeutics, January 2011;33(1):127-37. Epub 2010 Nov 2
44 NCI CAM ANNUAL REPORT 2010

Accelerating Progress in Cancer Prevention
Prevention is our first line of defense against cancer. Efforts to prevent 

cancer focus on understanding and modifying behaviors that increase risk, 

mitigating the influence of genetic and environmental risk factors, and 

interrupting cancer-causing processes through early medical intervention.

45 ACCELERATING PROGRESS IN CANCER PREVENTION
46 NCI CAM ANNUAL REPORT 

A c c e l e r a t i n g 

P r o g r e s s i n 

Prevention

C a n c e r 

2010

Division of 

Cancer Prevention

Exercise May Stop Cancer from 

Spreading to the Brain

Michal Toborek, M.D., Ph.D., has 

devoted much of his research to 

the blood-brain barrier, which 

appears to have an important 

role in some metastatic cancers. 

Metastases are the cause of most cancer deaths, 

said Dr. Toborek, “and the number of people 

who develop cancer in the brain (primary or 

metastatic) each year is enormous, probably 

around 200,000 in the United States alone.” 

Only about 1 in 9 of these people have primary 

brain tumors, he added, while the rest develop 

metastatic brain cancer that originated in 

other organs.

For years, researchers have been trying to learn 

about and prevent the process of metastasis. 

Because metastatic cancer cells travel through 

the bloodstream, if they are turned away by 

the blood-brain barrier, you will prevent 

cancer metastasis to the brain, explained Dr. 

Toborek, who is a professor in the Department 

of Neurosurgery at the University of Kentucky. 

The capillaries feed the brain with nutrients 

from the bloodstream such as glucose and 

amino acids, he said. There are certain protein 

structures known as transporter systems that 

recognize and send these vital nutrients across 

the blood-brain barrier, he continued, but other 

foreign substances and other cells that arrive via 

the capillaries – from cancer and other diseases 

– are recognized as intruders and cannot get 

into the brain. 

What stops them are the endothelial cells that 

make up the barrier and stick together like 

bricks. The metaphor extends to the “mortar” 

that holds them together, which are various 

types of adhesion molecules, Dr. Toborek 

said. What is new about his research is the 

recognition that exercise helps to keep these 

joints tightly bound together; they are referred 

to as “tight junctions.” It has been found 

that these junctions can be compromised by 

oxidative stress, which often occurs when any 

of a number of foreign substances – tumor cells 

or cells from the body’s hormone and immune 

systems – arrive at the blood-brain barrier, 

he commented. 

With NCI support,* Dr. Toborek’s lab is 

studying how certain proteins that fortify 

these tight junctions against oxidative stress 

are enhanced by exercise. They have developed 

a mouse model to explore this phenomenon. 

The mice are trained as runners on a wheel in 

their cage, and are genetically engineered to 

be especially vulnerable to brain metastases. 

After some animals are rigorously trained for 

5 weeks, and others remain sedentary, the 

researchers inject lung cancer cells into their 

carotid arteries, which is the access route that 

metastatic cancer cells would naturally travel 

in the circulatory system if they were headed 

for the brain. The results showed that the 

fit animals had dramatically fewer cases of 

brain metastases.

If the promising findings in the mouse studies 

can be confirmed in clinical trials of human 

patients, the public health impact of this line 

of research could be significant, Dr. Toborek 

commented. “This work follows a lot of 

compelling evidence that show that exercise 

reduces cancer risk by up to 50 percent in breast 

and colon cancer,” he noted. The challenge is 

that currently 3 in 5 Americans don’t exercise 

regularly and 1 in 4 Americans are limited to a 

sedentary lifestyle, he added. 

*Grant number: 

1R01CA133257-01A2
47 

A c c e l e r a t i n g 

P r o g r e s s i n 

C a n c e r 

Prevention

ACCELERATING PROGRESS IN CANCER PREVENTION

Division of 

Cancer Prevention

Compound in Cruciferous Vegetables 

Studied Against Pancreatic Cancer

“Eat your broccoli – it’s good for 

you” is a common refrain of 

many parents. Subrata Haldar, 

Ph.D., a pharmacology researcher 

at Case Western Reserve University, would agree. Dr. Haldar and his colleague 

Aruna Basu, Ph.D., are interested in the possible anti-cancer effects of a compound that is 

produced when our digestive system breaks 

down certain substances found in abundance 

in broccoli and other cruciferous vegetables, 

including cabbage and cauliflower. 

With support from NCI*, Drs. Basu and Haldar are exploring whether the compound benzyl 

isothiocyanate, or BITC, that is produced when 

consuming these vegetables could be used to 

help prevent or even treat pancreatic cancer. 

“Pancreatic cancer is one of the most aggressive 

malignancies in the world,” and few effective 

treatments are available, noted Dr. Haldar. 

Several epidemiological studies have shown that 

frequent consumption of cruciferous vegetables 

is linked with a reduced risk of some types of 

cancer, including pancreatic cancer. Moreover, 

preliminary studies by Drs. Haldar and Basu 

showed that BITC impairs the ability of pancreatic cancer cells grown in the laboratory to 

proliferate, or multiply. 

BITC is produced when microbes that live in 

the human gut break down substances called 

glucosinolates, which are plentiful in cruciferous vegetables. “BITC readily accumulates 

in the cell at high concentrations, and it is a 

multi-target compound that can attack multiple signaling pathways [in the cell] simultaneously,” making it appealing as an anti-cancer 

agent, Dr. Haldar noted. One key goal of Drs. 

Basu and Haldar’s current study is to determine the molecular mechanism by which BITC 

inhibits the growth of pancreatic cancer cells. 

In a series of recent experiments, they found 

that BITC alters the levels of microRNAs in 

pancreatic cancer cells. 

MicroRNAs are small RNA molecules that 

regulate gene expression, the process by which 

a gene gets turned on in a cell to make proteins. 

These small RNA molecules help regulate 

gene expression by preventing the translation 

of target genes. In translation, the information 

in genes is converted, or “translated,” into proteins. There are many types of microRNAs and 

a single microRNA can block the translation of 

hundreds of genes.

Studies in patients with pancreatic cancer have 

revealed that levels of a select set of microRNAs 

are altered in pancreatic ductal adenocarcinoma 

(PDAC), the most common type of pancreatic 

cancer, as compared to levels in normal pancreas 

or benign pancreatic tissue. Researchers 

discovered that the levels of one microRNA, 

miR-221, commonly go up in PDAC patients, 

whereas the levels of another microRNA, 

miR-375, go down in these patients. Drs. 

Haldar and Basu found that in laboratorygrown pancreatic cancer cells treated with 

BITC, miR-221 levels went down, while 

miR-375 levels went up – in other words, the 

effects of BITC on these microRNAs were 

the opposite of what was seen in people with 

pancreatic cancer. 

These findings suggest that BITC may target 

the levels of certain microRNAs “to switch 

hyperproliferative (rapidly dividing) cancer cells 

to a hypoproliferative (slower dividing) state,” 

said Dr. Haldar – that is, to stop cancer cells 

from growing out of control. “These microRNAs 

have been shown to have important roles in 

other cancers too,” he added.

Drs. Haldar and Basu are now working to see 

whether BITC has similar effects on microRNA 

in a mouse model of pancreatic cancer and, if so, 

whether those effects can prevent the development of pancreatic cancer or even help treat 

the disease in mice. If the findings in mice are 

promising, the researchers hope that eventually 

BITC could be tested in humans. 

“Our investigation is now focused on whether 

we can reprogram microRNA networks in pancreatic cancer which would hold the potential of 

an important therapeutic and preventive target” 

if such findings can be extended to humans, 

Dr. Haldar added.

*Grant number: 

5R03CA137476-02
48 NCI CAM ANNUAL REPORT 2010

A c c e l e r a t i n g 

P r o g r e s s i n 

C a n c e r 

Prevention

Division of 

Cancer Prevention

Vitamin A Studied as Possible Preventive 

Agent Against Cancer

V

itamin A is an essential nutrient 

that plays a crucial role in a wide 

range of biological processes, from 

bone growth and vision to immune 

function and cellular maturation. 

Compounds derived from vitamin A have been 

used to treat cancer with mixed results. The 

vitamin’s role in cancer appears to be complex: 

recent evidence suggests that, in certain circumstances, it may inhibit cancer in some, but 

promote cancer in others. Nevertheless, a large 

body of scientific literature supports the role 

of vitamin A in blocking the proliferation and 

maturation of breast cancer cells. Unfortunately, 

the doses required to achieve these effects produce adverse side effects and therefore cannot be 

used for cancer prevention.

An alternative and potentially less toxic approach might be to find a way to deliver immature forms (or precursors) of vitamin A to breast 

cells and make use of the cells’ own machinery 

to turn the precursors into retinoic acid (the 

active form of vitamin A), explains Matthew J. 

Rowling, Ph.D., of Iowa State University, who 

is being funded by NCI* to determine how 

to optimally use vitamin A for breast cancer 

prevention. 

Because the mechanisms by which vitamin 

A enters breast cells are poorly understood, it 

has not been clear how to deliver the vitamin A 

precursors into the cells. Dr. Rowling’s research 

initially focused on a group of cell-membrane 

proteins that are found in breast cells and 

had previously been shown to be essential in 

enabling both vitamin D and retinol (the main 

circulating form of vitamin A) to gain entry 

into kidney cells. A series of experiments, 

however, failed to show that these proteins were 

actively involved in helping retinol gain entry 

to breast cells. Then scientists at the University 

of California Los Angeles (UCLA) published 

a paper** in which they identified a receptor, 

dubbed STRA6, that separates retinol from its 

binding protein and ushers it inside cells, where 

it is then broken down. These experiments were 

conducted in cells from the retina (the membrane at the rear of the eyeball that is important 

for vision), raising the question as to whether 

STRA6 also facilitates retinol uptake in other 

types of cells. 

Dr. Rowling turned his attention to trying to 

elucidate whether STRA6 is the mechanism 

by which vitamin A enters cancer cells or cells 

susceptible to cancer. His experiments to date 

seem to confirm that the mechanism described 

by the UCLA scientists is at work not only in 

breast cells but also in colon and prostate cells. 

“Our thinking now is that STRA6 is essential 

for the uptake and anti-proliferative effects of 

vitamin A in breast, colon, and prostate cells,” 

he said. “A corollary to this is that if STRA6 

is missing or disabled, vitamin A–mediated 

control of cell proliferation might be lost, 

creating the conditions for a cancer to develop. 

A deficiency of STRA6 could be a marker for 

increased risk for breast, colon, or prostate 

cancer.”

If follow-up studies confirm this hypothesis, 

Dr. Rowling’s research could lead to novel 

approaches to cancer prevention by boosting 

vitamin A uptake in these organs.

*Grant number: 

5R03CA128091-03

**Kawaguchi R, Yu J, Honda J, et al. A membrane receptor for retinol binding protein mediates cellular uptake of vitamin A. 

Science, 2007;315(5813):820-5.
49 

A c c e l e r a t i n g 

P r o g r e s s i n 

C a n c e r 

Prevention

ACCELERATING PROGRESS IN CANCER PREVENTION

Division of 

Cancer Prevention

Vitamin D Tested for Preventing Lung Cancer in 

High-Risk Patients

A

t the Roswell Park Cancer Institute 

(RPCI) in Buffalo, New York, more 

than a decade’s worth of work developing vitamin D-based approaches 

to cancer therapy has produced some 

possible options and hope for the millions of 

current and former smokers at high risk for 

lung cancer. “The burden of lung cancer is not 

shouldered exclusively by people who continue 

to smoke cigarettes,” explained Mary E. Reid, 

Ph.D., associate professor of oncology and 

Director of Collaborative Research at RPCI. 

“While 40-50 million Americans have stopped 

smoking, their risk of developing lung cancer remains high for as many as 30 years after 

smoking cessation.” And there are still many 

people who have been unable to stop smoking, 

despite the known risks, she added. 

This is where calcitriol (1,25-dihydroxycholecalciferol) – the primary active form of vitamin 

D – comes in. Normally, the body takes in 

vitamin D through foods like fish and milk, 

dietary supplements, and produces its own 

vitamin D with the aid of sunlight. Vitamin D 

exerts its effect on the body via the vitamin D 

receptor (VDR) which is found in the cells of 

many types of tissues, including the lungs and 

prostate gland. Calcitriol has shown promise in 

preventing lung, prostate, and other cancers, 

Dr. Reid explained. She was the senior author 

on a study* that was the first to demonstrate 

that VDR is expressed in many different 

types of human lung tissue, from normal cells 

through the spectrum of precancerous changes, 

to full-blown tumors. 

With NCI funding**, RPCI will soon begin 

a Phase II clinical trial testing calcitriol as a 

preventive agent in people at high risk for 

lung cancer, Dr. Reid reported. But first, the 

U.S. Food and Drug Administration (FDA) 

has asked RPCI scientists to conduct a small 

pilot study on 40 current and former smokers 

between ages 40-80 from their High Risk Lung 

Cancer Cohort. It will determine the safety of 

the proposed dose of calcitriol they are planning 

to use for the larger Phase II prevention study. 

The patients in the pilot study will receive 

45 micrograms of calcitriol every other week for 

3 months, Dr. Reid explained. A common daily 

dose of calcitriol for patients with low calcium 

levels is 0.25 micrograms per day. Clinicians 

have found at least some form of precancerous 

tissue in the lungs of these patients – all 

of whom suffer from chronic obstructive 

pulmonary disease (COPD) – by passing a 

bronchoscope through the mouth or nose into 

the lungs to examine and collect samples. 

Dosing toxicities (or side effects) in the pilot 

study are graded from 1 through 4, with grades 

1 and 2 being less serious. The pilot study will 

not only look for any grade 3 or 4 toxicities in 

the calcitriol dose but will also report any other 

adverse effects to the FDA. Since 1999, RPCI 

researchers have conducted 6 clinical trials 

studying calcitriol and this dosage level has 

never produced any high-grade toxicities, 

and only a handful of low-grade toxicities, 

Dr. Reid said.

“I feel it’s important to be able to offer these 

high-risk patients some real options,” Dr. Reid 

commented. “They are fully aware that lung 

cancer can amount to a death sentence, and even 

so some are unable to quit smoking. Generally 

they are very happy to faithfully take a pill that 

reduces their risk, as long as there are no serious side effects. We see so many people at the 

clinic with COPD and damage to their airways, 

usually from smoking or other environmental 

exposures.” The current standard of care in the 

United States is simply to screen such patients 

routinely to detect changes in their lung and 

airway tissue indicating early cancer. “Understandably people want, and deserve more,” 

she said.

The Phase II trial that will follow the pilot 

safety study will provide calcitriol for 6 months 

to about half of the patients. The remaining 

patients, serving as a control group, will get 

a placebo for only the first 6 months and will 

then receive calcitriol for another 6 months, 

Dr. Reid said. “All study participants will be 

getting at least some of the treatment that we 

believe may be effective in preventing progression of any disease they may be harboring,” 

she concluded. 

*Menezes RJ, Cheney RT, Husain A, Tretiakova M, Loewen G, Johnson CS, Jayaprakash V, Moysich KB, Salgia R, Reid, ME. 

Vitamin D receptor expression in normal, premalignant, and malignant human tissue. Cancer Epidemiology, Biomarkers and 

Prevention, May 2008;17(5):1104-10. 

**Grant number: 

5R01CA112238-04
A c c e l e r a t i n g 

P r o g r e s s i n 

C a n c e r 

Prevention

50 NCI CAM ANNUAL REPORT 2010

Division of 

Cancer Prevention

Black Raspberries Studied To Prevent Oral Cancer

T

he Ohio State University (OSU) Comprehensive Cancer Center and College 

of Public Health have a long and successful tradition of studying food for its 

health and anticancer properties. One 

of the well-studied components found in ripe 

black raspberries is anthocyanins, which give 

the berries their deep purple color. A number 

of studies in different animals (such as rats and 

hamsters) have shown that a liquid mixture 

of these fruits taken orally interferes with the 

growth of tumors in the oral cavity, esophagus, 

and colon. 

“We think the primary reason that the berry 

mixture inhibits cancer is because it makes 

physical and biological contact with the precancerous tissue all along the digestive route of the 

animals,” noted Christopher Weghorst, Ph.D., 

a professor of Environmental Health Sciences 

and Otolaryngology at OSU. He said that many 

of the compounds found in black raspberries are 

not well absorbed through the digestive system 

into the bloodstream. “This certainly includes 

some of the components we think might be 

responsible for the protective effect we are 

finding,” he added. “We and others have also 

designed some novel delivery methods aimed at 

extending the period of time the berry components remain in contact with the target tissue.”

Many CAM researchers face a dilemma when 

trying to determine which ingredient in a food 

plant is responsible for the health effects they 

find in their studies, said Dr. Weghorst. While 

it is often possible to isolate just a single compound from the plant, test it for activity against 

a particular health problem, and then produce 

(and market) it as a supplement, “this may not 

be the best approach,” he commented. “In fact, 

there is a lot of evidence to the contrary.”

The study that NCI is funding* in Dr. Weghorst’s lab is not intended to isolate and test the 

anthocyanins in black raspberries that many believe are the “active ingredient.” Instead, he is 

testing the relative importance of anthocyanins 

by using green berries before they fully ripen 

into black raspberries. Anthocyanins are not 

developed in green berries because the fruit has 

not yet ripened. In hamsters, when the green 

berries were compared to the ripe raspberries, 

their inhibiting impact on oral cancer in the 

test animals was about the same, he reported.

One possible mode of action for the berries’ 

beneficial impact on cancer cells may involve 

gankyrin, a cancer-causing gene (or oncogene) 

“that produces a cell growth stimulus and is 

over-expressed in head and neck cancers,” said 

Dr. Weghorst. “Both the green and the ripe 

black raspberries reduced the expression of this 

oncogene to a more normal level. Thus, the anthocyanins cannot logically be the sole cause.” 

On the other hand, the researchers found that 

the P16 tumor suppressor gene, which is often 

inactivated in oral cancers, was found in abundance in animals given the ripe black raspberries but not in those given the green berries. 

Thus, there are numerous helpful ingredients 

in the berries which can change gene expression 

patterns in a manner that might favor cancer 

prevention, Dr. Weghorst explained. 

“All of this demonstrates there are multiple 

pathways involved in this type of cancer development and cancer prevention,” Dr. Weghorst said. “We now know that that there are 

also bioactive components of the green forms 

of these plants that are effective against oral 

cancer.” This helps confirm the food-based approach to cancer prevention, even using food at 

various stages of ripeness, he believes, and emphasizes the capability of the complex mixtures 

of chemicals found in “whole” foods to inhibit 

multiple processes of cancer development.

These types of animal studies have set the stage 

for larger studies in humans, Dr. Weghorst 

stated. One such study already underway is 

evaluating the molecular effects of ripe black 

raspberries on “at risk” normal oral cells in 

post-surgical oral cancer patients. “Oral cancer 

has a strong connection with alcohol consumption and smoking,” he noted, “and reducing 

these behaviors would have a really dramatic 

impact.” But proving the preventive value of 

berries could enhance the options available to 

people, despite the consequences of their past 

behaviors or their personal risk of cancer recurrence, he commented.

*Grant number: 

5R03CA137798-02
51 ACCELERATING PROGRESS IN CANCER PREVENTION
52 52 NCI CAM ANNUAL REPORT NCI CAM ANNUAL REPORT 20102010

Developing Effective and Efficient Treatments
The development of more efficient and effective cancer treatments – that target 

cancer cells while leaving surrounding healthy tissue unharmed – is at the heart 

of NCI’s research agenda. We strive to develop well-tolerated, individualized 

therapies that are tailored to specific features of a patient’s cancer.

53 DEVELOPING EFFECTIVE AND EFFICIENT TREATMENTS
54 NCI CAM ANNUAL REPORT 2010

D e v e l o p i n g 

E ff e c t i v e a n d 

E ff i c i e n t 

Treatments

Division of Cancer 

Treatment and 

Diagnosis

Special Electric Signals Attack Cancer 

Cells with Lethal Force and Accuracy

D

irecting X-ray energy into the body 

has been a mainstay of cancer therapy 

since early in the 20th century, but an 

entirely different approach using electric pulses now shows great promise. 

The first research center in the United States 

devoted to this burgeoning field of electroporation (EP) was established about a decade ago at 

Old Dominion University in Norfolk, Virginia, 

where Andrei G. Pakhomov, Ph.D., currently 

works as a research associate professor in cell 

biology and biophysics.

“The idea is to deliver electric pulses of extremely short duration through an electrode 

directly to a tumor,” Dr. Pakhomov explained. 

If the pulses last only a matter of nanoseconds 

(a few billionths of a second), they create an 

electric field that blows open pores in the 

cellular membrane and disrupts the internal 

workings of the cell. 

Nanosecond electrical pulses (nsEP) are bad 

news for the cancer cell in a many ways, Dr. 

Pakhomov noted. For example, the cellular membrane normally balances electrically 

charged molecules inside and outside the cell, 

but when the pores open up, the cell loses 

control of what’s going in and out. This change 

in the permeability of the membrane leads to 

osmotic imbalance, where “ions pour into the 

cell, followed by water, you get swelling, and 

more swelling until they eventually explode,” 

he added. “This is a form of necrotic cell death.”

The good news for cancer researchers is that 

killing cells by high-power electric pulses 

is virtually without side effects, because the 

intervention is carefully delivered directly to 

the tumor site and has little effect on nearby 

tissue, Dr. Pakhomov said. Other researchers 

have shown that a single treatment using 

nsEPs has killed melanoma cells in mice. The 

exciting results from such early work has made 

many researchers eager to further test nsEPs in 

animals and eventually in people. 

However, researchers still need to figure out 

many of the details about how nsEP works and 

how the electric pulses might be modified to 

match their targets. “I think that we’re going 

to find different mechanisms for different kinds 

of cancer,” he explained, “because nsEPs have 

the power to cause both apoptotic and necrotic 

damage.”

Apoptosis – also known as programmed cell 

death – is a housekeeping process that cleans 

out unwanted cells by interfering with various 

cell survival functions. Many cancer cells are 

resistant to this process, leading researchers to 

develop drugs and therapies that induce apoptosis in various ways. “Apoptotic death is very 

clean,” Dr. Pakhomov continued, “with less 

pain and inflammation [to the patient] and no 

scarring. We can control nsEPs very precisely 

to induce apoptosis when we want, but some 

researchers maintain that the immune reaction 

is actually an important part of the fight against 

cancer.” 

Dr. Pakhomov’s NCI-funded work* is laying 

the groundwork for a therapy that clinicians 

will be able to adapt according to the type of 

cancer they are targeting. By altering the characteristics of the electrical pulse (such as pulse 

width, voltage, and duration of the pulse train), 

the signal can be tailored to the target tissue. 

This is important, he said, because preliminary 

studies have shown that, while most cancers are 

vulnerable to nsEPs, they differ in how resistant 

they are, and at what point in their basic cell 

cycle they are most vulnerable. He foresees a 

time when the pulse delivery system will be 

sophisticated enough to allow doctors to create 

a mix of pulses that will target different types 

of tumor tissue at different times and with a 

combination of certain drugs.

*Grant number: 

5R01CA125482-03
55 

D e v e l o p i n g 

E ff e c t i v e a n d 

E ff i c i e n t 

Treatments

DEVELOPING EFFECTIVE AND EFFICIENT TREATMENTS

Division of 

Cancer Prevention

Soy Bread Studied in Men with Prostate Cancer

C

ompared with men in the United 

States, men living in many Asian 

nations have a lower risk of prostate 

cancer. “If you look at what factors may 

contribute to the differences in risk, 

one of the many variables that jumps out is 

the much greater consumption of soy in Asia,” 

said Steven Clinton, M.D., Ph.D., a professor 

of Medical Oncology at Ohio State University 

(OSU), who studies the role of dietary factors in 

prostate and other cancers. 

Research in Dr. Clinton’s laboratory and elsewhere – including studies in mouse models 

of prostate cancer – have shown that certain 

phytochemicals (chemicals that are found in 

plants) in soy have potential anti-prostatecancer properties. However, the ability of soy 

to help prevent or treat prostate cancer in men 

remains unproven.

One of the challenges researchers face in studying this question is coming up with a convenient – and tasty – way to incorporate adequate, 

well-defined amounts of soy phytochemicals 

into the typical Western diet. With support 

from NCI*, Yael Vodovotz, Ph.D., an associate 

professor in OSU’s Department of Food 

Science and Technology, is collaborating with 

Dr. Clinton to compare two types of soy bread 

that the researchers developed for that purpose. 

The soy bread “provides in two slices a dose of 

soy phytochemicals that would be similar to 

that consumed daily by many Asian populations,” said Dr. Clinton.

The researchers are focusing on soy bread as 

a so-called functional food (foods that have 

potential health benefits, beyond just basic 

nutrition), rather than giving people individual 

soy phytochemicals, and in particular, soy 

compounds known as isoflavones. “The idea is 

that not only the isoflavones, but also the other 

components of soy may be very critical” for the 

biological effects in humans, Dr. Vodovotz said. 

She said that using soy bread as a “phytochemical delivery system” allows researchers to create 

a consistent product, yet provide a complex 

variety of soy components. 

The OSU researchers are conducting a small 

clinical study to compare two types of soy bread 

as a source of phytochemicals in the diet. Both 

varieties contain isoflavones, but one of the 

breads includes an enzyme that yields twice as 

much of an altered form of isoflavone, known as 

the aglycone form, Dr. Vodovotz explained. The 

aglycone form is believed to be more biologically active and more readily absorbed from the 

digestion into the bloodstream than unaltered 

forms of isoflavones.

The 40 men in the study all had active prostate 

cancer and rising prostate specific antigen 

(PSA) -a biological marker of prostate cancerlevels but were not undergoing active therapy 

during the 20-week study period. For the first 

8 weeks, half of the men ate three slices per day 

of the regular soy bread, while the other half 

ate three slices daily of the aglycone-enriched 

bread. After a 2-week, soy-free period, each 

study participant ate the other form of soy 

bread for another 8 weeks.

The researchers found that about 90% of the 

men could eat the soy breads on a daily basis 

without any difficulties, while about 5% experienced very minor gastrointestinal distress. No 

other serious problems were observed, 

Dr. Clinton said. “Overall, the majority of men 

found the food easily incorporated into the 

diet, and some men are even purchasing soy 

bread that is now on the market, while others 

are making their own soy bread at home,” he 

noted. “At least a third of the men suggested 

that we need to improve the product to make 

it competitive with breads available on the 

market.”

The researchers are analyzing blood samples 

from the men and running a range of tests to 

find out whether the aglycone form of isoflavones is in fact better absorbed and has a greater 

effect on various biomarkers that have been 

linked with anti-cancer activity.

Once the final results are in, the researchers 

hope to use an optimized form of soy bread in 

clinical trials that will rigorously test the ability 

of soy phytochemicals to improve the treatment 

of prostate cancer or to prevent the disease in 

men who are considered at high risk. Dr. Vodovotz commented, “We hope to eventually have 

the bread in a commercially available form, because if you’re going to recommend something 

for prostate cancer, it better be available in the 

marketplace.”

*Grant number: 

R21CA125909-02
56 NCI CAM ANNUAL REPORT 

D e v e l o p i n g 

E ff e c t i v e a n d 

E ff i c i e n t 

Treatments

2010

Division of Cancer 

Treatment and 

Diagnosis

Clinical Trial Inspired by Breast Cancer Cells, 

Cows, and Collaboration

With more than 13 years of 

experience running early 

phase clinical trials, Raymond 

Perez, M.D., currently the 

Medical Director of the 

Clinical Research Center at the University of 

Kansas, knows that in early drug development 

“you can’t sustain a clinical program with just 

one line of research. You have to look all over 

for opportunities for treatments that are ready 

to test in people, and help investigators make 

that happen.”

Dr. Perez and his former colleague William Kinlaw, M.D., Professor of Medicine at 

Dartmouth Medical School (where Dr. Perez 

led the Phase I clinical trials program at the 

Norris Cotton Cancer Center from 1998 until 

2011 before heading to Kansas) have pursued 

one such opportunity down a winding path 

from basic lipid metabolism studies to testing in dairy cows, and now to an early phase, 

NCI-funded clinical trial* testing conjugated 

linoleic acid (CLA) as a targeted anti-cancer 

agent.

About 10 years ago, Dr. Perez heard Dr. 

Kinlaw give a presentation on a protein called 

Spot 14, which helps cells produce necessary 

fatty acids from glucose. When the researchers 

blocked Spot 14 with an antisense nucleotide 

(a single strand of DNA or RNA, produced 

in the lab, which will bind to a corresponding section of DNA or RNA in the cell and 

interfere with production of proteins), they 

saw breast cancer cells die in laboratory cell 

cultures. “After Dr. Kinlaw’s presentation, 

I approached him and started talking about 

Spot 14 and he’d never really thought about it 

therapeutically,” recounted Dr. Perez.

Over the next several years, Dr. Kinlaw, an 

endocrinologist by training, moved his laboratory over to the Norris Cancer Center and 

his team engaged in a frustrating search for a 

drug to potentially target Spot 14 in people. 

No pharmaceutical company would commit to producing antisense against Spot 14, 

he said. Some drugs that he and Dr. Kinlaw 

tested in animals – such as Cerulenin (an 

antifungal agent) – were too toxic. Other 

drugs – such as Orlistat (a weight-loss drug) – 

were not absorbed into the bloodstream after 

oral administration.

The researchers put the idea of an anti-Spot 

14 therapy aside for a while and concentrated 

on understanding its biology, showing that 

the protein is a marker for aggressive primary 

breast cancers.** Then, serendipitously, 

Dr. Kinlaw received a call from Dale Bauman, 

Ph.D., a professor of animal science at Cornell 

University. Dr. Bauman had been looking at a 

condition in dairy cows called milk-fat depression. The condition happens when cows eat 

plants in the wild that contain linoleic acid. 

Bacteria in their stomachs convert linoleic 

acid into another compound called conjugated 

linoleic acid (CLA), which is absorbed into 

the blood stream and suppresses milk-fat 

production.

In an experiment, he had fed some cows 

linoleic acid-containing plants and gave 

other cows injections of pure CLA, and then 

performed microarray analysis to analyze gene 

expression changes. “The biggest hit he got 

from both was that Spot 14 was turned off,” 

Dr. Kinlaw recalled. “Dr Bauman had never 

heard of Spot 14 before so he called me out of 

the blue.” Interestingly, CLA also interfered 

with an enzyme called lipoprotein lipase, 

which cancer cells can use to extract fatty acids from the local circulatory bed, Dr. Kinlaw 

added. 

“We had a series of discussions about this and 

the obvious thing that came up was that if 

CLA could shut down lipid synthesis in the 

cows’ mammary epithelial cells, maybe it 

could do the same thing in malignant human 

epithelial cells,” Dr. Kinlaw commented. “We 

got some CLA and tested it in breast cancer 

and liposarcoma cells, and it inhibited their 

growth quite promptly.” ***

CLA is used as a dietary supplement and had 

shown no severe side effects in a clinical trial 

testing it for weight loss, Dr. Kinlaw continued. He and other investigators performed a 

*Grant number: 

5R21CA131820-02
57 DEVELOPING EFFECTIVE AND EFFICIENT TREATMENTS

small proof-of-concept pharmacology trial in 23 

women diagnosed with breast cancer. Between 

the 10 to 12 days from diagnosis to mastectomy, 

the women received 7.5 grams of CLA per day 

and then tissue taken during their surgeries was 

examined for Spot 14. “CLA significantly turned 

down Spot 14 in the tumors, so it did seem to 

actually work in humans,” Dr. Kinlaw noted. 

“We realized that CLA might be the compound 

that could hit this target; now we have to prove 

it,” Dr. Perez said. In the ongoing Phase I trial, 

they will first determine the recommended 

therapeutic dose of CLA. The study dose will 

be escalated in patients until side effects are 

observed or the larger doses no longer increase 

the effect of CLA on Spot 14, he added. In this 

first part of the trial, samples of fat tissue from 

patients will be used to measure the activity 

of CLA. 

Once the recommended dose has been determined, a second group of patients will be given 

CLA and tumor biopsies will be taken to make 

sure CLA is hitting its target in the tumors, 

Dr. Perez continued. The researchers will also 

look at the effect of CLA on proteins involved in 

the Spot 14 signaling pathway that also play a 

role in fat metabolism and examine the compound’s effects on cell proliferation, apoptosis 

(programmed cell death), and other measurements of tumor growth.

Dr. Kinlaw is currently writing a grant application to study the mechanisms behind CLA’s 

effects on Spot 14 in more detail, and also to 

explore how the compound might be most 

effectively delivered to tumors, using mice 

genetically engineered to lack either Spot 14 

or lipoprotein lipase. “These are pretty good 

models to help us figure out how CLA might 

be working in humans,” he said.

**Wells WA, Schwartz GN, Morganelli PM, Cole BF, Gibson JJ, Kinlaw WB. Expression of Spot 14 (THRSP) predicts disease 

free survival in invasive breast cancer: immunohistochemical analysis of a new molecular marker. Breast Cancer Research and 

Treatment, July 2006;98(2):231-40. Epub March 22, 2006.

***Donnelly C, Olsen AM, Lewis LD, Eisenberg BL, Eastman A, Kinlaw WB. Conjugated linoleic acid (CLA) inhibits expression 

of the Spot 14 (THRSP) and fatty acid synthase genes and impairs the growth of human breast cancer and liposarcoma cells. 

Nutrition and Cancer, 2009;61(1):114-22.
Improving the Quality of Life for Cancer Patients, 

Survivors, and their Families

58 NCI CAM ANNUAL REPORT 2010
Advances in our ability to detect, treat, and support cancer patients have turned 

this disease into one that is chronic, or readily managed, for many and curable 

for increasing numbers. While the ultimate goal of eliminating cancer altogether 

continues to be our long-term commitment, the capacity to dramatically reduce 

the suffering caused by cancer is within our immediate grasp.

59 IMPROVING THE QUALITY OF LIFE FOR CANCER PATIENTS, SURVIVORS, AND THEIR FAMILIES
60 NCI CAM ANNUAL REPORT 2010

I m p r o v i n g t h e 

Q u a l i t y o f L i f e f o r 

C a n c e r P a t i e n t s , 

S u r v i v o r s , a n d 

their Families

Division of Cancer 

Control and 

Population Sciences

Yoga Studied to Relieve Fatigue and Stress in 

Breast Cancer Patients

B

reast cancer survivors confront a 

number of post-treatment problems. 

Persistent fatigue, the most common 

and distressing problem, appears to be 

related in part to patients’ inflammatory responses to various stressors from their 

disease and its aftermath. 

“The best treatment that we know about to 

remedy this problem is exercise,” noted Janice 

Kiecolt-Glaser, Ph.D., who holds the S. Robert 

Davis Chair of Medicine in The Ohio State 

University College of Medicine. “But the 

problem is, of course, that if you’re pretty tired 

and feeling that you don’t have a lot of energy, 

one of the last things you want to do is exercise.” With NCI funding*, she is conducting a 

clinical trial of a gentle regimen of hatha yoga 

(which is physically less demanding than other 

forms of yoga) “that we thought could be quite 

useful in terms of reducing fatigue, and potentially inflammation at the same time.” 

Dr. Kiecolt-Glaser and her colleagues have enrolled approximately 200 women, ages 40 and 

older, who have been diagnosed with stage I, II, 

or IIIA breast cancer. The women have all completed cancer treatment within the past year 

(except for tamoxifen/aromatase inhibitors), 

and will not start in the study until at least 

two months after their surgery and completion of adjuvant chemotherapy or radiation (if 

any). They will be assigned to either a 12-week, 

twice-weekly hatha yoga intervention or to 

a delayed “wait list” group who will receive 

the yoga intervention after a 6-month observation period.

The researchers will measure differences between the two groups at the start (baseline) of 

the study, at 3 months (at the conclusion of the 

12-week yoga intervention), and at 6 months. 

Also at baseline and 3 months, responses of 

inflammation-related molecules to a laboratory 

stressor will be assessed. The primary aim is to 

determine if the yoga intervention will decrease 

inflammation, fatigue, and depressive symptoms relative to the wait-listed group. 

They will also determine the extent to which 

the intervention affects psychological, behavioral, and physical functioning; evaluate the 

relationship between depressive symptoms and 

the magnitude of the physiological responses 

elicited by a laboratory stressor, as well as the 

relationship of both to fatigue; and assess the 

extent to which the yoga intervention decreases 

physiological stress responses.

Although they have not yet analyzed data on 

the two comparison groups of breast cancer patients because the trial is still in progress, “the 

women in the yoga group have been incredibly 

enthusiastic about it once they actually get into 

the program,” Dr. Kiecolt-Glaser noted. “We 

have small groups that we schedule around the 

women’s availability. The yoga groups meet 

twice a week and they’re encouraged strongly to 

practice at home and we’re getting pretty good 

compliance in terms of actual home practicing 

as well.”

If the study results prove positive, yoga could 

be a good addition to standard medical care for 

these types of patients, she added. “We believe 

yoga should be able to offer a lot of other physical benefits in the way that modest exercise 

does, such as increased flexibility. Yoga could 

also serve as a ‘gateway’ exercise to other, perhaps more strenuous, kinds of exercise programs 

for these patients.”

*Grant number: 

5R01CA126857-05
61 

I m p r o v i n g t h e 

Q u a l i t y o f L i f e f o r 

C a n c e r P a t i e n t s , 

S u r v i v o r s , a n d 

their Families

IMPROVING THE QUALITY OF LIFE FOR CANCER PATIENTS, SURVIVORS, AND THEIR FAMILIES

Division of 

Cancer Prevention

Electroacupuncture May Counter Patients’ 

Nausea After Chemotherapy

Many cancers are treated with chemotherapy agents that circulate 

throughout the body. When the 

drugs reach organs and tissues not 

affected by cancer, they can cause 

adverse side effects. Among the most prevalent 

and troublesome side effects are nausea and 

vomiting, though recently a new class of 

molecules – known as 5HT3 agonists, and 

used in combination with corticosteroid 

dexamethasone pills – have been found to 

help reduce or even prevent these symptoms. 

“But those drugs [5HT3 agonists] work 

effectively only against what we call acute-onset 

nausea and vomiting,” said Dr. Jiande Chen, 

Ph.D., professor of Medicine at the University 

of Texas Medical Branch. “Once you get past 

the first day, many patients suffer from delayed 

nausea and vomiting, which is really a different problem altogether, can last for many hours 

or several days, and is much more difficult to 

treat.” Patients with advanced cancer can also 

develop chronic nausea symptoms. 

Older patients and others can wear down 

from the rigors of chemotherapy and many are 

reluctant to add yet another medication to their 

treatment regimen, especially if it is supposed 

to counter symptoms that were caused by medication in the first place. For example, with a 

drug like cisplatin, “it is not uncommon to find 

patients choosing to discontinue chemotherapy 

altogether – even when it is effectively treating 

their cancer – in order to avoid these debilitating side effects,” explained Dr. Chen.

In China, there is widespread use and acceptance of acupuncture to treat nausea. “It is 

encouraging to find more and more practitioners and patients in the United States willing 

to accept this therapy,” he said. Acupuncture 

relies on the stimulation of very precise points 

on the body located beneath the skin. Each of 

these “acupoints” is associated with pain or 

other symptoms at a specific, usually distant, 

site in the body. After several thousand years of 

use, acupuncture practitioners have been able to 

develop detailed “body maps” for these points. 

Two of the acupoints that inhibit nausea 

and vomiting have been found to be PC6 – 

a few inches above the inside of the wrist – and 

ST36 – slightly below and behind the knee, 

Dr. Chen explained. In previous studies, needles 

inserted at these points and then manually manipulated have produced some results, but they 

were only partial responses, and worked only 

against acute vomiting after chemotherapy. 

Dr. Chen believes those mixed results were 

due, not to any limits in acupuncture per se, 

but rather to how it has been applied. With 

NCI funding*, Dr. Chen and his colleagues 

have been testing electroacupuncture (EA), to 

see if it is even more effective than traditional 

acupuncture against chemotherapy-induced 

nausea. Electroacupuncture is a procedure in 

which pulses of weak electrical current are sent 

through acupuncture needles into acupuncture 

points in the skin. Using rats and dogs, their 

current study is testing the precise location 

and depth the acupuncture stimulation should 

be applied; whether to use EA before or after 

chemotherapy, or both; whether the regimens 

should be continuous; and also the frequency 

and intervals of the electric pulses themselves.

The researchers are working on several aspects 

of EA that would be important in delivering 

therapy to patients for whom current antiemetics (drugs to counter nausea and vomiting) are not working. That group potentially 

includes the majority of patients with delayed 

or chronic nausea and vomiting. 

Dr. Chen believes that a successful series of 

experiments with the EA approach could have 

a major impact on treating symptoms that 

threaten the quality of life of cancer patients. 

“This EA therapy has no discernible side effects 

on the patient, and therefore we can give it 

chronically, as necessary, to respond to symptoms,” he added. Dr. Chen and his colleagues 

are also testing a system where a small power 

stimulator is implanted in the abdomen of the 

experimental animals, with conducting wires 

leading under the skin to electrodes that have 

been carefully inserted at the acupoints. The 

researchers will be able to trigger the EA stimulation by an external transmitter, but ultimately 

Dr. Chen foresees a time when patients will be 

able to control a similar system themselves. 

*Grant number: 

1R21CA149956-01
62 NCI CAM ANNUAL REPORT 

I m p r o v i n g t h e 

Q u a l i t y o f L i f e f o r 

C a n c e r P a t i e n t s , 

S u r v i v o r s , a n d 

their Families

2010

Division of Cancer 

Control and 

Population Sciences

Behavioral Stress Management Program, Even in 

Small Doses, May Help Breast Cancer Patients

O

ver the past 20 years, Professor 

Michael Antoni, Ph.D. and his 

colleagues at the University of 

Miami have received NCI support 

to research and develop the Cognitive Behavioral Stress Management (CBSM) 

intervention for women recovering from breast 

cancer. CBSM – a 10-week program that combines cognitive behavioral therapy techniques, 

relaxation training, and learning interpersonal 

skills – has proven successful in helping many 

patients achieve improvements in multiple 

indicators of psychosocial adaptation after 

treatment, including better social and psychological functioning and less intrusive thoughts 

and social disruption.* 

These successes have led to the adoption of the 

CBSM program by the University of Miami 

Sylvester Comprehensive Cancer Center and by 

numerous other cancer centers in the United 

States. However, Dr. Antoni cautions that 

the full 10-week program – which includes 

2-hour sessions each week – can be difficult for 

some breast cancer patients to participate in, 

either due to debilitating symptoms from their 

illness and treatments, scheduling, transportation problems, or other concerns. This has 

led him and his colleagues to explore whether 

condensed or alternative formats for delivering 

CBSM will make the intervention a realistic 

option for more patients.

With NCI funding**, Dr. Antoni is currently 

studying two 5-week, partial versions of CBSM. 

Dr. Antoni reported that “previous research has 

shown that women who had attended on average 5 of the 10 CBSM sessions did just about as 

well as did women who attended 8-10 sessions, 

and did much better than women who only 

attended 1-2 sessions.” 

The investigators also discovered that two components of CBSM provided most of the beneficial effects for breast cancer patients. “One 

thing from the intervention that seemed to be 

accounting for most of the positive effects was 

relaxation training and the patients’ confidence 

in using relaxation skills,” Dr. Antoni recalled. 

“One other variable that seemed to drive most 

of the effects was the amount of time the women 

were spending each week in expressing their 

emotions” with cognitive behavioral therapy. 

“This suggests that shorter forms of the CBSM 

intervention – focusing on elements of the 

full intervention such as cognitive behavioral 

therapy techniques or on relaxation training 

skills – might be a cost-effective way to facilitate adaptation among a larger portion of the 

population of women receiving treatment for 

breast cancer,” Dr. Antoni said.

As a result, the current study is randomizing 

women, newly diagnosed with Stages I to 

III breast cancer, into three groups: 1) cognitive behavioral therapy; 2) relaxation training 

intervention; or 3) an attention-social support 

control. Groups of 80 individuals each will run 

for 5 weeks. 

While that study is running, Dr. Antoni is also 

planning research into new delivery formats – 

including teleconferencing, videophone, and 

Internet Skype technologies – to bring CBSM 

directly to patients’ homes. “A lot of breast 

cancer patients are suffering side effects during 

treatment, like fatigue, that might make it 

hard for them to attend even a 5-week group,” 

he noted. “We want to be able to reach those 

patients.” 

Dr. Antoni and his colleagues are studying 

bringing CBSM “to the community for the 

lower-income minority patients.” They’re currently testing whether CBSM works in women 

from one lower income African- American community, he said. “We’re running groups in the 

churches and community health centers that 

serve these women.”

In addition, Dr. Antoni added, they will delve 

further into their earlier research findings on the 

biological impact of CBSM on breast cancer patients. In previous CBSM studies, they collected 

blood samples from study participants and 

“found reductions in serum cortisol (a marker of 

stress) and changes in immune system activity 

such as increases in lymphocyte proliferative 

responses and increased Th-1 cytokine production (interferon-gamma and interleukin-2),” he 

noted. Dr. Antoni and his colleagues are now 

examining other molecules involved in stress 

response and seeing how they change following 

participation in the CBSM program. 

*Antoni M, Wimberly S, Lechner S, Kazi A, Sifre T, Urcuyo K, Phillips K, Smith R, Petronis V, Guellati S, Wells K, Blomberg 

B, Carver C. Reduction of cancer-specific thought intrusions and anxiety symptoms with a stress management intervention 

among women undergoing treatment for breast cancer. American Journal of Psychiatry, October 2006;163:1791-1797.

**Grant number: 

5R01CA064710-14
63 

I m p r o v i n g t h e 

Q u a l i t y o f L i f e f o r 

C a n c e r P a t i e n t s , 

S u r v i v o r s , a n d 

their Families

IMPROVING THE QUALITY OF LIFE FOR CANCER PATIENTS, SURVIVORS, AND THEIR FAMILIES

Division of Cancer 

Control and 

Population Sciences

Tai Chi Exercise Studied to Improve Quality 

of Life for Senior Cancer Survivors

T

here are over 28 million cancer 

survivors worldwide and the majority of these survivors are over age 60. 

Compared to elderly individuals who 

have never had cancer, both short-term 

and long-term elderly cancer survivors are more 

likely to report worse quality of life (QOL), 

high rates of psychological distress, poorer 

general health status, and more functional 

limitations. Mind-body exercise interventions 

have been suggested as a way to improve both 

mental and physical aspects of QOL in cancer 

patients who are undergoing or who have completed treatment. However, few studies have 

been conducted among older cancer survivors.

Anita Kinney, Ph.D., Jon & Karen Huntsman 

Presidential Professor in Cancer Research at 

Huntsman Cancer Institute and the Department of Internal Medicine, University of Utah, 

explained that Tai Chi Chih (TCC), a westernized version of Tai Chi Chuan, is a mind-body 

program designed for use in the elderly and 

medically compromised populations. TCC is 

considered to be a moderate-intensity aerobic 

exercise that consists of a combination of slow, 

deliberate movements and meditation.

With NCI funding*, Dr. Kinney is conducting 

a randomized controlled clinical trial to determine the feasibility and preliminary efficacy 

of TCC for improving physical performance, 

mental and physical health-related QOL, and 

biomarkers associated with stress, inflammation, and healthy aging among senior, female 

cancer survivors. “We have enrolled 64 women, 

ages 55 and older,” she noted. “About 84% of 

our enrollees are breast cancer survivors. Initially, 

the study was focusing solely on breast cancer 

survivors but there was a large community 

interest for enrolling women who had other 

types of cancer. We felt that it was important 

to be responsive to the community’s interest 

and address the needs of other female sedentary 

cancer survivors.”

The women are randomized to the TCC or a 

health education control (HEC) group. They all 

receive 12 weeks of TCC or HEC, for 60 minutes, 3 times a week, for a total of 36 sessions. 

“We evaluate them for physical performance,” 

Dr. Kinney noted. “They come into our Cancer 

Institute’s Wellness Center and receive exams 

by physical fitness professionals. Then we 

collect their survey data to assess their QOL. 

We also collect blood samples to test for some 

biomarkers. We’re measuring the TCC intervention’s effects on inflammatory cytokines, as 

well as on cortisol which is a stress biomarker 

and also oxytocin which has been coined the 

‘happy’ hormone.” 

The trial is ongoing, but Dr. Kinney is hopeful the study’s data will provide support for the 

feasibility and the potential health benefits of a 

TCC program for senior, female cancer survivors. If so, she plans to seek NCI funding for a 

larger, multi-site randomized clinical trial. “We 

hope that if our findings are borne out in a larger trial, this may pave the way for mind-body 

exercise interventions to become a routine part 

of cancer wellness care,” Dr. Kinney explained. 

“We hope the studies will provide evidence to 

policy-makers for the inclusion of TCC and 

similar types of interventions into survivorship 

care plans and for third-party payers reimbursing cancer survivors for TCC.” 

*Grant number: 

5R21CA135250-02
64 NCI CAM ANNUAL REPORT 2010

SCIENTIFIC PUBLICATIONS

This is a selected list of some of the most important peer-reviewed scientific 

articles about the finding and analyses of NCI-supported CAM research studies 

published during FY 2010. The articles are classified and grouped according 

to research type: cancer prevention, cancer treatment, cancer side effect/

symptom management and quality of life/survivorship.

Article citations marked with an asterisk (*) are studies which were featured 

in the NCI’s Annual Report on Complementary and Alternative Medicine: 

Fiscal Year 2009, which can be read and downloaded from http://www.

cancer.gov/cam/attachments/nci_cam_annual_report_fy09.pdf.

Abstracts of all the articles are available online through the National Library 

of Medicine’s “PubMed” database at http://www.pubmed.com.

Prevention

*Adhami VM, Khan N, Mukhtar H. Cancer 

chemoprevention by pomegranate: laboratory 

and clinical evidence. Nutrition and Cancer, 

2009;61(6):811-5.

*Aslam MN, Kreider JM, Paruchuri T, Bhagavathula N, DaSilva M, Zernicke RF, Goldstein 

SA, Varani J. A mineral-rich extract from the 

red marine algae Lithothamnion calcareum 

preserves bone structure and function in female 

mice on a Western-style diet. Calcified Tissue 

International, 2010 Apr;86(4):313-24. Epub 

2010 Feb 24.

*Aslam MN, Paruchuri T, Bhagavathula N, 

Varani J. A mineral-rich red algae extract 

inhibits polyp formation and inflammation in 

the gastrointestinal tract of mice on a highfat diet. Integrative Cancer Therapies, 2010 

Mar;9(1):93-9.

Nath RG, Wu MY, Emami A, Chung 

FL.Effects of epigallocatechin gallate, L-ascorbic 

acid, alpha-tocopherol, and dihydrolipoic acid 

on the formation of deoxyguanosine adducts 

derived from lipid peroxidation. Nutrition and 

Cancer, 2010;62(5):622-9.

Sarkar FH, Li Y, Wang Z, Kong D. Novel 

targets for prostate cancer chemoprevention. Endocrine-Related Cancer, 2010 Aug 

16;17(3):R195-212. Print 2010 Sep.

Zick SM, Ruffin MT, Djuric Z, Normolle 

D, Brenner DE. Quantitation of 6-, 8- and 

10-Gingerols and 6-Shogaol in Human Plasma 

by High-Performance Liquid Chromatography with Electrochemical Detection. International Journal of Biomedical Science, 2010 

Sep;6(3):233-240.

Treatment

Ansenberger K, Richards C, Zhuge Y, Barua A, 

Bahr JM, Luborsky JL, Hales DB. Decreased 

severity of ovarian cancer and increased survival 

in hens fed a flaxseed-enriched diet for 1 year. 

Gynecologic Oncology, 2010 May;117(2):341-7. 

*Luo W, Karpf AR, Deeb KK, Muindi JR, 

Morrison CD, Johnson CS, Trump DL. Epigenetic regulation of vitamin D 24-hydroxylase/

CYP24A1 in human prostate cancer. Cancer 

Research, 2010 Jul 15;70(14):5953-62.

*Muindi JR, Yu WD, Ma Y, Engler KL, Kong 

RX, Trump DL, Johnson CS. CYP24A1 inhibition enhances the antitumor activity of calcitriol. 

Endocrinology, 2010 Sep;151(9):4301-12.
65 SCIENTIFIC PUBLICATIONS

Sarkar FH, Li Y, Wang Z, Kong D. The role 

of nutraceuticals in the regulation of Wnt and 

Hedgehog signaling in cancer. Cancer Metastasis 

Reviews, 2010 Sep;29(3):383-94.

*Shoulars K, Rodriguez MA, Thompson T, Markaverich BM. Regulation of cell cycle and RNA 

transcription genes identified by microarray analysis of PC-3 human prostate cancer cells treated 

with luteolin. Journal of Steroid Biochemistry 

Molecular Biology, 2010 Jan;118(1-2):41-50.

Volate SR, Kawasaki BT, Hurt EM, Milner JA, 

Kim YS, White J, Farrar WL. Gossypol induces 

apoptosis by activating p53 in prostate cancer 

cells and prostate tumor-initiating cells. Molecular Cancer Therapeutics, 2010 Feb;9(2):461-70. 

Wang Z, Ahmad A, Banerjee S, Azmi A, Kong 

D, Li Y, Sarkar FH. FoxM1 is a novel target of a 

natural agent in pancreatic cancer. Pharmaceutical Research, 2010 Jun;27(6):1159-68. Epub 

2010 Mar 31.

Wang Z, Li Y, Sarkar FH. Notch signaling 

proteins: legitimate targets for cancer therapy. 

Current Protein & Peptide Science, 2010 Sep 

1;11(6):398-408.

*Wei G, Wang M, Carr BI. Sorafenib combined 

vitamin K induces apoptosis in human pancreatic 

cancer cell lines through RAF/MEK/ERK and 

c-Jun NH2-terminal kinase pathways. Journal of 

Cellular Physiology, 2010 Jul;224(1):112-9.

*Wei G, Wang M, Hyslop T, Wang Z, Carr BI. 

Vitamin K enhancement of sorafenib-mediated 

HCC cell growth inhibition in vitro and in vivo.

International Journal of Cancer, 2010 

Dec 15;127(12):2949-58

Side Effect/Symptom Management

Kwan ML, Darbinian J, Schmitz KH, Citron 

R, Partee P, Kutner SE, Kushi LH. Risk factors 

for lymphedema in a prospective breast cancer 

survivorship study: the Pathways Study. Archives 

of Surgery, 2010 Nov;145(11):1055-63.

Kiecolt-Glaser, J. Stress, Food, and Inflammation: Psychoneuroimmunology and Nutrition 

at the Cutting Edge. Psychosomatic Medicine, 

2010 May;72(4):365–369.

*Lyon DE, Schubert C, Taylor AG. Pilot study 

of cranial stimulation for symptom management 

in breast cancer. Oncology Nursing Forum, 2010 

Jul;37(4):476-83.

Vargas S, Wohlgemuth WK, Antoni MH, 

Lechner SC, Holley HA, Carver CS. Sleep 

dysfunction and psychosocial adaptation 

among women undergoing treatment for 

non-metastatic breast cancer. Psychooncology,

2010 Jun;19(6):669-73.

Quality of Life/Survivorship

Kwan ML, Ergas IJ, Somkin CP, Quesenberry 

CP Jr, Neugut AI, Hershman DL, Mandelblatt 

J, Pelayo MP, Timperi AW, Miles SQ, Kushi LH. 

Quality of life among women recently diagnosed 

with invasive breast cancer: the Pathways Study. 

Breast Cancer Research and Treatment, 2010 

Sep;123(2):507-24. 
66 NCI CAM ANNUAL REPORT 

APPENDIX

An NCI-supported clinical trial meets one or more of the following criteria: the protocol (1) has been reviewed and approved 

by NCI’s CTEP Protocol Review Committee or by an approved NCI-designated Cancer Center Protocol Review and Monitoring 

System and/or (2) receives support through an NCI grant, contract, or cooperative agreement.

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Pediatric Trials

Phase III Randomized Study of Acupressure to 

Control Chemotherapy-Induced Nausea in Children 

With Central Nervous System or Solid Tumors 

Receiving Cisplatin-Containing Chemotherapy

COG-ACCL1032 Active Supportive care 4 to 18 NCI Phase III

Phase III Randomized Study of Glutamic Acid in 

Reducing Vincristine-Related Peripheral Neurotoxicity in Young Patients Undergoing VincristineContaining Treatment for Wilms’ Tumor, 

Rhabdomyosarcoma, Acute Lymphoblastic 

Leukemia, or Non-Hodgkin’s Lymphoma

SCUSF-0402 Active Supportive care, Treatment 3 to 20 NCI Phase III

Randomized Study of Electroacupuncture for Treatment of Delayed Chemotherapy-Induced Nausea 

and Vomiting in Patients With Newly Diagnosed 

Pediatric Sarcoma, Neuroblastoma, Nasopharyngeal Carcinoma, Germ Cell Tumors, or Hodgkin 

Lymphoma

NCCAM-02-AT-0172 Active Supportive care 5 to 35 NCI Phase I

Adult Trials

Bladder

Green Tea Extract in Treating Patients With 

Nonmetastatic Bladder Cancer

CDR0000594276 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase II

Brain

Phase II Randomized Study of Adjuvant Boswellia 

serrata and Standard Treatment Versus Standard 

Treatment Alone in Patients With Newly Diagnosed 

or Recurrent High-Grade Gliomas

CASE-CCF-7348 Active Treatment 18 and over NCI Phase II

Breast

Diindolylmethane in Treating Patients With Breast 

Cancer

10-0366-04 Active Biomarker/Laboratory analysis, 

Diagnostic, Treatment

19 and over NCI Phase III, 

Phase II

Phase II/III Study of Curcumin in Patients With 

Breast Cancer With Radiation-Induced Dermatitis

URCC-10054 Active Biomarker/Laboratory analysis, 

Supportive care, Treatment

21 and over NCI Phase III, 

Phase II

Acupressure for Persistent Cancer Related Fatigue CA151445 Active Supportive care 18 to 75 NCI Phase III, 

Phase II

Phase III Randomized Study of Cranial Microcurrent 

Electrical Stimulation in Reducing ChemotherapyRelated Symptoms in Women With Stage I-IIIA 

Breast Cancer Receiving Adjuvant Chemotherapy

MCV-MCC-11995 Active Biomarker/Laboratory analysis, 

Supportive care

Adult NCI Phase III

2010
67 NCI CAM ANNUAL REPORT 

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Adult Trials

Phase III Randomized Study of Omega-3-Fatty Acid 

in Treating Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness in Patients With Stage I, II, 

or IIIA Breast Cancer

SWOG-S0927 Approved-not 

yet active

Biomarker/Laboratory analysis, 

Prevention

Not specified NCI Phase IIl

Menopause and Meditation for Breast Cancer 

Survivors

1R21CA106336-01A1 Active Supportive care 30 to 70 NCI Phase II, 

Phase I

Phase II Randomized Study of High-Dose 

Cholecalciferol in Premenopausal Women at 

High-Risk for Breast Cancer

SWOG-S0812 Approved-not 

yet active

Biomarker/Laboratory analysis, 

Supportive care

18 to 50 NCI Phase II

IH636 Grape Seed Extract in Preventing Breast 

Cancer in Postmenopausal Women at Risk of 

Developing Breast Cancer

03178 Active Prevention 40 to 75 NCI Phase II

Acupuncture in Reducing Muscle and Bone 

Symptoms in Women Receiving Letrozole, 

Exemestane, or Anastrozole for Stage 0, Stage I, 

Stage II, or Stage III Breast Cancer

JHOC-J07110, 

CDR0000589108

Active Biomarker/Laboratory analysis, 

Supportive care, Treatment

18 and over NCI Phase II

Broccoli Sprout Extract in Treating Women Who 

Have Had a Mammogram and Breast Biopsy

CDR0000634111 Active Biomarker/Laboratory analysis, 

Treatment

21 and over NCI Phase II

Phase II Randomized Pilot Study of a CommunityBased Yoga Intervention Versus an Educational 

Wellness Intervention in Women With Stage I-III 

Breast Cancer Undergoing Chemotherapy

CCCWFU-97309 Active Educational/Counseling/Training, 

Supportive care

18 and over NCI Phase II

Soy Isoflavones and Breast Cancer Risk Reduction 03-260 Active Prevention 30 to 42 NCI Phase II

The Effect of Soy Protein on Post- Breast Cancer 

Surgery Pain

A02-M102-07A Active Supportive care 21 and over NCI Phase II

Study of CoQ10 During One Cycle of Doxorubicin 

Treatment for Breast Cancer

AAAD8521 Active Supportive care, Treatment 21 and over NCI Phase I

Cook for Your Life AAAE9701 Active Behavioral study, Biomarker/

Laboratory analysis, Educational/

Counseling/Training

21 and over NCI No phase 

specified

Randomized Study of Vitamin D and Breast 

Cancer Biomarkers in Female Patients

CALGB-70806 Active Biomarker/Laboratory analysis, 

Prevention

55 and under NCI No phase 

specified

Randomized Study of Hatha Yoga in Improving 

Physical Activity, Inflammation, Fatigue, and 

Distress in Female Breast Cancer Survivors

OSU-2007C0004 Active Biomarker/Laboratory analysis, 

Supportive care

21 and over NCI No phase 

specified

Effects of Tibetan Yoga on Fatigue and 

Sleep in Cancer

2005-0035 Active Supportive care 18 and over NCI No phase 

specified

2010
68 NCI CAM ANNUAL REPORT 

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Adult Trials

Venlafaxine and Hypnosis or Focused Attention In 

Treating Patients With Hot Flashes

MC09C7 Active Supportive care 18 and over NCI No phase 

specified

Randomized Study of Education With or Without 

Exercise and Counseling in Preventing Lymphedema 

in Women With Stage I-III Breast Cancer Who Are 

Undergoing Axillary Lymph Node Dissection

CALGB-70305 Active Supportive care, Treatment 18 and over NCI No phase 

specified

Cervix

Phase II Study of Folic Acid Supplementation in 

Women Infected With HPV-16 and Diagnosed With 

Grade 1 or Less Cervical Intraepithelial Neoplasia 

UAB-F060511015 Active Biomarker/Laboratory analysis, 

Prevention

19 and over NCI Phase II

Randomized Study of Mindfulness-Based Stress 

Reduction Versus General Health Education in 

Improving Immune Response to Human Papilloma 

Virus in Patients With Cervical Dysplasia

FCCC-06851 Active Behavioral study, Biomarker/

Laboratory analysis, Educational/

Counseling/Training

18 and over NCI No phase 

specified

Colon/Rectum

Phase III Study of the Effect of Vitamin E and/or 

Selenium on Adenomatous Colorectal Polyps in 

Men Enrolled on SELECT Trial SWOG-S0000 

SWOG-S0000D Active Natural history/Epidemiology, 

Prevention

50 and over NCI Phase III

Selenium for Prevention of 

Adenomatous Colorectal Polyps 

CDR0000353185 Active Prevention 40 to 80 NCI Phase III

Cholecalciferol(25-[OH]-Vitamin D) in Treating 

Patients With Colorectal Cancer 

CASE2210 Approved-not 

yet active

Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase II

Phase II Randomized Study of Acupuncture in 

Reducing Postoperative Ileus in Patients Who Have 

Undergone Segmental or Subtotal Colectomy for 

Colorectal Cancer 

MSKCC-06145 Active Supportive care Over 18 NCI Phase II

Vitamin E Supplements in Treating Patients 

Undergoing Surgery for Colorectal Cancer 

CDR0000642446 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase I

Phase I/II Randomized Study of Inositol for the 

Prevention of Colorectal Cancer in Patients With 

Colitis-Associated Dysplasia

NU-NWU09-13-02 Active Biomarker/Laboratory analysis, 

Prevention

18 and over NCI Phase I

Randomized Pilot Study of Oncologist Recommended Home-Based Exercise Program Versus 

Relaxation Training for Physical Functioning and 

Symptom Control in Patients With Unresectable 

Stage IV or Recurrent Colon Cancer

MDA-2009-0288 Active Behavioral study, Supportive care 18 and over NCI No phase 

specified

Head/Neck

Phase III Randomized Study of Acupuncture for 

Radiation-Induced Xerostomia in Patients With 

Head and Neck Cancer

MDA-04-01 Approved-not 

yet active

Supportive care Not specified NCI Phase III

Xerostomia Acupuncture Trial 2010-0584 Approved-not 

yet active

Supportive care 18 and over NCI Phase III

Phase II Randomized Chemoprevention 

Study of Bowman-Birk Inhibitor Concentrate in 

Patients With Oral Leukoplakia

UCIRVINE-UCI-98-34 Active Biomarker/Laboratory analysis, 

Prevention, Treatment

18 and over NCI Phase II

2010
69 NCI CAM ANNUAL REPORT 

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Adult Trials

Curcumin Biomarker Trial in Head and Neck Cancer H08-081 Active Biomarker/Laboratory analysis, 

Treatment

18 to 90 NCI No phase 

specified

Hematologic

Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance 

and/or Smoldering Multiple Myeloma

CDR0000646899 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase II 

Efficacy of NF-kB Inhibition for Reducing Symptoms 

During Maintenance Therapy in Multiple Myeloma 

Patients

2010-0457 Approved-not 

yet active

Supportive care, Treatment 18 and over NCI Phase II

Lactobacillus in Preventing Infection in Patients 

Undergoing a Donor Stem Cell Transplant for 

Hematologic Cancer or Myelodysplastic Syndrome

CDR0000649274 Active Supportive care 18 and over NCI No phase 

specified

Lung

Exercise and Lung Cancer Trial 00018255 Active Behavioral study 21 to 80 NCI Phase lll

Phase II Randomized Study of Manuka Honey for 

the Reduction of Chemoradiation Therapy-Induced 

Esophagitis-Related Pain During Treatment in 

Patients With Lung Cancer

RTOG-1012 Approved-not 

yet active

Supportive care, Treatment 18 and over NCI Phase II

Green Tea Extract in Treating Current or Former 

Smokers With Bronchial Dysplasia

CDR0000578224 Active Biomarker/Laboratory analysis, 

Prevention

45 to 74 NCI Phase II

Phase II Randomized Study of Inositol for the 

Prevention of Lung Cancer in Current or Former 

Smokers With Bronchial Dysplasia

MAYO-MAY06-8-01 Active Biomarker/Laboratory analysis, 

Prevention

45 to 79 NCI Phase II

Calcitriol in Preventing Lung Cancer in Smokers 

and Former Smokers at High Risk of Lung Cancer

CDR0000596506 Active Biomarker/Laboratory analysis, 

Prevention

40 to 79 NCI Phase I

Phase I Randomized Pilot Study of Dietary Flaxseed 

Supplementation in Patients With Locally Advanced 

or Metastatic Non-Small Cell Lung Cancer Undergoing Definitive Chemoradiotherapy

UPCC-03309 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase I

Multiple

Phase II Pilot Study of Magnesium Oxide in Treating 

Menopausal Hot Flashes in Women With Cancer

MCV-MCC-12062 Active Supportive care 18 and over NCI Phase II

A Molecular Pharmacodynamic Dose-titration Trial 

of Conjugated Linoleic Acid (CLA; Clarinol®) in 

Patients With Advanced Solid Tumors

D0914 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase I

Yoga-Based Cancer Rehabilitation Program #2000-007 Active Behavioral study, Supportive care 18 and over NCI No phase 

specified

Randomized Study of Magnetic Acupressure in 

Reducing Pain in Cancer Patients Undergoing Bone 

Marrow Aspiration and Biopsy

JHOC-J07103 Active Diagnostic, Supportive care 18 and over NCI No phase 

specified

Pilot, Randomized Study of Mindfulness Relaxation 

Versus Relaxing Music Versus Standard Symptom 

Management Education in Patients With Newly 

Diagnosed Solid Tumors Undergoing Chemotherapy

MDA-CCC-0106 Active Educational/Counseling/Training, 

Supportive care

Over 18 NCI No phase 

specified

2010
70 NCI CAM ANNUAL REPORT 

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Adult Trials

Pilot Randomized Study of Cognitive-Behavioral 

Therapy Versus Standard Care in Patients With 

Advanced Gastrointestinal Cancer or Lung Cancer

MGH-2007-P-000368 Active Educational/Counseling/Training, 

Supportive care

Over 18 NCI No phase 

specified

White Wine or Nutritional Supplement in Improving 

Appetite in Patients With Cancer

RC08C6 Active Supportive care 21 and over NCI No phase 

specified

No Specific Cancer Type/Healthy Volunteer

Clinical Trial of Vitamin D3 to Reduce Cancer Risk 

in Postmenopausal Women

CAPS08-15024 Active Prevention 55 and over NCI Phase III

Phase III Randomized Study of a Psychoeducation, 

Paced Respiration, and Relaxation Intervention for 

Caregivers of Patients Undergoing Bone Marrow 

Transplantation

UCHSC-080303 Active Biomarker/Laboratory analysis, 

Educational/Counseling/Training, 

Supportive care

18 and over NCI Phase II 

Phase I Pilot Study of Resveratrol in Postmenopausal Women With High Body Mass IndexUARIZ-UAZ08-12-01 Active Biomarker/Laboratory analysis, 

Prevention

35 and over NCI Phase l

Exercise or Relaxation for Smoking Cessation 09-097-2 Active Behavioral study 50 and over NCI No phase 

specified

Patient-Directed Lifestyle Change and Health 

Promotion Program or Usual Care in Low-Income, 

Uninsured Participants in Los Angeles County, 

California

CDR0000561559 Active Behavioral study, Educational/

Counseling/Training, Health services 

research

18 and over NCI No phase 

specified

Studying the Effect of Freeze-Dried Table 

Grape Powder on Blood Estrogen Levels in 

Postmenopausal Women

CDR0000581219 Active Biomarker/Laboratory analysis, 

Prevention

18 and over NCI No phase 

specified

Cruciferous Vegetable Intake and Histone Status in 

Screening Colonoscopy Patients

P01 CA090890 Active Biomarker/Laboratory analysis, 

Prevention, Screening

50 to 75 NCI No phase 

specified

Soy Isoflavones Supplementation in Treating 

Women at High Risk For or With Breast Cancer

1B-10-6 Active Diagnostic, Prevention, Treatment 30 to 75 NCI No phase 

specified

Pilot Study of Educational and Promotional 

Materials Development For Use In Promoting 

Physical Activity In Community-Based After-School 

Programs By Multiethnic, Urban Adolescents

MSUHNS-0003669 Active Educational/Counseling/Training, 

Prevention

11 to 14 NCI No phase 

specified

Vitamin D and Omega-3 Trial (VITAL) 2009P-001217 Active Prevention 60 and over NCI No phase 

specified

Phase II Pilot Study of Electrical Stimulation 

Therapy Using the MC5-A Scrambler for the 

Management of Chronic ChemotherapyInduced Peripheral Neuropathy

MCV-MCC-12110 Approved-not 

yet active

Supportive care 18 and over NCI Phase II

Pancreas

Vitamin E d-Tocotrienol Administered to Subjects 

With Resectable Pancreatic Exocrine Neoplasia

MCC-15630 Active Treatment 18 and over NCI Phase I

Prostate

Phase II/III Randomized Study of Adjuvant Soy 

Protein Isolate in Preventing Recurrence in Patients 

Who Have Undergone Radical Prostatectomy for 

Stage II Prostate Cancer

UIC-2006-0706 Active Biomarker/Laboratory analysis, 

Treatment

40 to 75 NCI Phase Ill,

Phase Il

2010
71 NCI CAM ANNUAL REPORT 

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Adult Trials

Selenium in Preventing Prostate Cancer CDR0000654651 Approved-not 

yet active

Biomarker/Laboratory analysis, 

Prevention

Under 80 NCI/Other Phase lll

Improving Continence and Quality of Life in 

Prostate Cancer Patients

1R01CA127493-01A2 Active Health services research, 

Supportive care

21 and over NCI Phase lll

Phase I/II Study of the Effects of Tomato-Soy Juice 

on Biomarkers of Prostate and Cardiovascular 

Health in Patients With Prostate Cancer 

Undergoing Prostatectomy

OSU-2007C0026 Active Biomarker/Laboratory analysis, 

Treatment

Any age NCI Phase II, 

Phase I

Vitamin D and Soy Supplements in Treating 

Patients With Recurrent Prostate Cancer

CDR0000554969 Active Biomarker/Laboratory analysis, 

Treatment

Over 18 NCI Phase II 

Green Tea, Decaffeinated Black Tea, or 

Water in Treating Patients With Prostate 

Cancer Undergoing Surgery

CDR0000596162 Active Biomarker/Laboratory analysis, 

Treatment

40 to 75 NCI Phase II 

Study of Polyphenon E in Men With High-grade 

Prostatic Intraepithelial Neoplasia

MCC-15008 Active Biomarker/Laboratory analysis, 

Treatment

30 to 80 NCI Phase II

Selenium in Treating Patients With Prostate Cancer CDR0000614471 Active Biomarker/Laboratory analysis, 

Treatment

Under 85 NCI Phase II

Diindolylmethane in Treating Patients With Stage 

I or Stage II Prostate Cancer Undergoing Radical 

Prostatectomy

CDR0000641168 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase II

Genistein in Treating Patients With Prostate Cancer NCI 09U2 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI Phase II

Defined Green Tea Catechin Extract in 

Treating Patients With Localized Prostate 

Cancer Undergoing Surgery

CASE13805 Active Biomarker/Laboratory analysis, 

Treatment

45 to 75 NCI Phase II

Phase II Randomized Study of the Effect of an 

L-Arginine/Korean Ginseng/ Gingko Biloba/

Damiana-Based Supplement With or Without 

Phosphodiesterase-5 Inhibitors on Erectile Function 

and Quality of Life in Prostate Cancer Survivors 

Previously Treated With Radiotherapy

CCCWFU-98110 Approved-not 

yet active

Supportive care 18 and over NCI Phase II

Vitamin E Supplements in Preventing Cancer in 

Patients at Risk of Prostate Cancer or Who Have 

Prostate Cancer

CDR0000639070 Active Biomarker/Laboratory analysis, 

Prevention

18 and over NCI Phase I

White Button Mushroom Extract in Treating Patients 

With Recurrent Prostate Cancer After Local Therapy

08012 Active Biomarker/Laboratory analysis, 

Treatment

Any age NCI Phase I

Polyunsaturated Fatty Acids in Treating Patients 

With Prostate Cancer Undergoing Prostate Biopsy 

and/or Surgery

CDR0000538993 Active Biomarker/Laboratory analysis, 

Treatment

18 and over NCI No phase 

specified

Chemoprevention of Prostate Cancer, HDAC 

Inhibition and DNA Methylation

Portland VA-09-0607 Active Biomarker/Laboratory analysis, 

Prevention

21 and over NCI No phase 

specified

Randomized Study of Lycopene in Preventing 

Prostate Cancer in Healthy Participants

UIC-2004-0217 Active Biomarker/Laboratory analysis, 

Prevention

18 and over NCI No phase 

specified

Omega-3 Fatty Acids in Treating Patients With 

Advanced Prostate Cancer

CCCWFU 85108 Active Diagnostic, Treatment 18 and over NCI No phase 

specified

2010
72 NCI CAM ANNUAL REPORT 

PDQ Clinical Trials Protocol ID Current Status Type of Trial Age Range Sponsor of Trial Phase(s)

Adult Trials

Cancer Survivors

Phase II Randomized Study of Two Home-Based 

Interventions for Sleep-Wake Disturbances in 

Cancer Survivors

NCCTG-N07C4 Active Supportive care 18 and over NCI Phase II

The HEALS Project - Health Education and Active 

Living for Surviving Seniors

34851 Active Supportive care 55 to 90 NCI Phase I

Randomized Pilot Study of Hypnosis in Controlling 

Hot Flashes in Women Who are Breast Cancer 

Survivors

UIC-2004-0217 Active Biomarker/Laboratory analysis, 

Prevention

18 and over NCI No phase 

specified

Randomized Study of an L-Arginine-Based 

Nutritional Supplement (ArginMax®) in Female 

Cancer Survivors

CCCWFU-05-04-01 Active Supportive care Adult NCI No phase 

specified

Acupuncture for Sleep Disruption in Cancer 

Survivors

SU-04082010-5642 Active Supportive care 18 and over NCI No phase 

specified

2010
OCCAM ORGANIZATIONAL CHART

National Cancer Institute

Division of Cancer Treatment and 

Diagnosis

Office of Cancer Complementary and 

Alternative Medicine 

Office of the Director Case Review and Intramural Science Program

Director Director

 Administrative Program Specialist Program Coordinator

	 Office	Assistant CRTA Fellow

 Health Science Administrator

Scientific	Program	Analysts

 Interns and Fellows

Communications and Outreach Program

 Program Coordinator

	 Program	Analyst

 Health Communications Intern

Extramural Research Program

 Director

	 Program	Officer

 CRTA Fellow

73 NCI CAM ANNUAL REPORT 2010 

NIH Publication No. 11-7768

Printed February 2012

NIH...Turning Discovery into Health