National Cancer Institute Office of Cancer Complementary and Alternative Medicine AnnuAl RepoRt on 

Complementary 

and Alternative Medicine FiscAl YeAR 2008 

U.S. DEPARTMENT 

OF HEALTH AND 

HUMAN SERVICES 

National Institutes 

of Health 

Director’s Message

The 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, as well, to NCI’s complementary and alternative medicine program, also known as CAM. 

It is with great pleasure and pride that we once 

again provide NCI’s research partners, physicians, the advocacy community, policymakers 

and cancer patients with this fourth annual 

review of NCI’s extensive accomplishments in 

advancing evidence-based CAM interventions 

and therapies. 

While the study of CAM is challenging, 

we are fortunate to have many partners in this 

endeavor, as demonstrated in the brief research 

profiles you’ll find featured in this report. 

A significant new CAM partnership 

commenced in July 2008 when U.S. Department of Health and Human Services and the 

Chinese Health Ministry signed a landmark 

memorandum of understanding to foster collaboration between researchers who study 

integrative and traditional Chinese medicine 

in both countries. 

One of the first and most promising 

of these projects is a partnership between the 

Kunming Institute of Botany of China Academy 

of Sciences and NCI. The Kunming Institute 

supplies rare and promising specimens, while 

NCI’s Natural Products Branch of the Developmental Therapeutics Program screens them in 

their system of 60 human cancer cell lines. 

NCI’s Office of Cancer Complementary and 

Alternative Medicine does an excellent job of 

coordinating the endeavors that resulted from 

our agreement with the Chinese researchers 

and in developing the Institute’s CAM research 

portfolio and partnerships with extramural 

researchers as well as within NCI’s intramural 

programs. This effort expands our ability to 

extend the search for effective therapies into 

areas outside the mainstream of 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 that they are considering. It is 

our duty to conduct the science that makes 

wise and informed decisions possible. 

John E. Niederhuber, M.D. 

Director 

National Cancer Institute 

D I R E C T O R ’ S M E S S A G E 1 
The following acronyms are used throughout this report: 

NCI National Cancer Institute 

CAM complementary and alternative medicine 

OCCAM Office of Cancer Complementary and Alternative Medicine 

DCB Division of Cancer Biology 

DCTD Division of Cancer Treatment and Diagnosis 

CCR Center for Cancer Research 

DCEG Division of Cancer Epidemiology and Genetics 

FY fiscal year 

RDSP Research Development and Support Program 

PAP Practice Assessment Program 

BCS Best Case Series 

COP Communications and Outreach Program 

NCCAM National Center for Complementary and Alternative Medicine 

NIH National Institutes of Health 

CARRA Consumer Advocates in Research and Related Activities 

MOU Memorandum of Understanding 

TCM Traditional Chinese Medicine 

CRTA Cancer Research Training Award 

PDQ Physicians Data Query 

CIS Cancer Information Service 

FASEB Federation of American Societies for Experimental Biology 

CBT cognitive behavioral therapy 

ACCC Arizona Comprehensive Cancer Center 

UA University of Arizona 

FOA Funding Opportunity Announcement 

RFA Request for Applications 

PA physical activity 

HDAC histone deacetylases 

PPT Polyp Prevention Trial 

ESCC esophageal squamous cell carcinoma 

PAH polycyclic aromatic hydrocarbons 

PanINs pancreatic intraepithelial neoplasias 

EGCG epigallocatechin-3-gallate 

CSC cancer stem cells 

DIM diindolylmethane 

PDGF platelet derived growth factor 

QOL quality of life 

TCC Tau Chi Chuan 

PMID PubMed Indentifier 
C O N T E N T S 3 

Contents

Director’s Message 1

Introduction 5 

Office of Cancer Complementary and Alternative Medicine 6 

NCI CAM Communications Programs 13 

Training and Conferences 18 

Highlights from NCI’s CAM Training Projects 24 

Nurses Trained to Do Presurgery Hypnosis for Breast Cancer Patients 26 

Psychologist Helps Breast Cancer Patients Cope with Radiation Treatment 28 

Expressive Writing Program May Help Advanced Breast Cancer Patients 30 

Career Mentors Bring Young Investigator into Promising Skin Cancer Prevention Work 32 

NCI Research in Complementary and Alternative Medicine 34 

NCI CAM Research Portfolio Analysis: FY 2008 35

Highlights from NCI’s Wide-Ranging CAM Research 40 

Understanding the Causes and Mechanisms of Cancer 42 

Chickens Studied for Ways to Prevent and Detect Ovarian Cancer 43 

Physical Activity Levels Studied in China for Impact on Cancer Risk 44 

Treating Metabolic Syndrome Is Studied to Reduce Pancreatic Cancer Risk 45 

Accelerating Progress in Cancer Prevention 46 

Kava Root Compound Shows Promise for the Prevention of Bladder Cancer 47 

Dietary Compounds that Affect the Epigenome Tested for Cancer Prevention 48 

Dietary Flavonols Tested for Colorectal Cancer Prevention 50 

Environmental and Nutritional Links to Esophageal Cancer Found Globally 52 

Green Tea Shows Promise in Preventing Pancreatic Cancer 53 

Ginger Extract to Be Tested for Lung Cancer Prevention 54 

Developing Effective and Efficient Treatments 56 

Plant Compounds Show Effects Against Prostate Cancer Stem Cells 57 

Traditional Chinese Medicine Treatment May Enhance Chemotherapy 58 

Cruciferous Vegetables Studied for Prevention and Treatment of Pancreatic Cancer 59 

Improving the Quality of Life for Cancer Patients, Survivors, and their Families 60 

Traditional Chinese Mind-Body Practice May Relieve Cancer Stress and Improve Quality of Life 61 

Breathing Exercises Studied to Ease Hot Flashes in Breast Cancer 62 

Scientific Publications 64 

Appendix 67 
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 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 prescription drugs, hormones, complex natural 

products, vaccines, and other biological interventions not yet accepted in mainstream medicine. 

Examples: Antineoplastions, 714X, Low dose naltrexone, Immunoaugmentative therapy, Laetrile, Hydrazine sulfate, Melatonin 

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 
Introduction

Each year, Congress requests a report of the 

National Cancer Institute’s (NCI) annual expenditures in complementary and alternative medicine* (CAM) research. To give more meaning 

to the numbers provided to Congress, a more 

detailed account of the Institute’s investment in 

CAM has been produced for the last three years. 

The reports, (including last year’s NCI’s Annual 

Report on Complementary and Alternative 

Medicine: Fiscal Year 2007), are intended as a 

way for NCI to communicate its progress in this 

area of medical research, not only to Congress, 

but also to other interested stakeholders including cancer researchers, CAM practitioners, 

health care providers, advocacy organizations, 

cancer patients, and the general public. 

This year, the NCI’s Office of Cancer 

Complementary and Alternative Medicine (OCCAM) is proud to present the latest such report, 

NCI’s Annual Report on Complementary 

and Alternative Medicine: Fiscal Year 2008. 

Similar to the previous reports, this publication 

provides an overview of NCI-supported work in 

this field along with details on selected CAM 

projects relating to research, communication, 

and training and conferences. 

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, 

Division of Cancer Prevention, and the Division 

of Cancer Treatment and Diagnosis (DCTD), 

along with projects from NCI’s intramural laboratories – 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. For the 

first time, this year’s report includes an analysis 

of the different types of training grant awards in 

NCI’s CAM research portfolio and summaries 

of some of these grants. In fiscal year (FY) 2008, 

NCI’s research expenditures for CAM are an 

estimated $121,264,507 for the funding of 

444 CAM research projects. 

As this report on cancer CAM indicates, 

we at the NCI are committed to an integrated 

approach to marshalling all of the many 

resources and approaches necessary to make 

cancer a condition that is – at worst – a manageable, chronic illness similar to heart disease and 

diabetes. We believe that evidence-based CAM 

techniques, systems, and products can have an 

important role in helping us reach 

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 means it 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.) 

I N T R O D U C T I O N 5 
 

Office of Cancer Complementary 

and Alternative Medicine 
NCI’s 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 DCTD. 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 Programs 

Research Development and 

Support Program 

As previously noted, NCI sponsored more than 

444 cancer CAM research projects in FY 2008, 

each of which is managed within the various Divisions and Centers of the Institute. OCCAM’s Research Development and Support Program (RDSP) 

staff manages a portion of this portfolio and works 

with other program staff throughout NCI, assists 

investigators in identifying funding opportunities, 

and provides guidance in the pre- and post-review 

periods of grant application. The RDSP 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. RDSP also works with other 

NCI program staff to fund new grants and supplements to existing grants. 

For example, OCCAM awarded a grant 

supplement during FY 2008 to Yale University 

researcher Dr. Yung-Chi Cheng for his study on 

“Nucleoside Analogs as Anti-cancer Compounds” 

(R01CA063477). The supplement supported research on the interaction of the herbal supplement 

PHY906 with the chemotherapy drug irinotecan. 

In addition, OCCAM awarded the following 

research grants to: 

• Dr. Rakesh Srivastava at the University of 

Texas Health Center at Tyler for his project 

“Chemoprevention of Pancreatic Cancer by 

EGCG.” (R01CA125262) 

• Dr. Fazlul Sarkar at Wayne State University in 

Detroit, Michigan for his project 

“A Novel and Targeted Approach to Inhibit 

Invasion and Angiogenesis.” (R01CA131151) 

• Dr. Shengmin Sang at North Carolina Central 

University, Kannapolis for his project “Ginger 

Extract Bioavailability Study and Lung Cancer 

Preventive Effect.” (R21CA138277) 

Journal Article on Survey of CAM Researchers 

OCCAM staff published the article “Survey of 

cancer researchers regarding complementary and alternative medicine” in the Journal of the Society for 

Integrative Oncology (Winter 2008; 16(1) 2-12). 

About 85% of the respondents had participated 

in cancer CAM research. For all CAM categories, 

the percentage of respondents who would like to 

conduct research was greater than the percentage of 

those who have already done so. About two-thirds 

of the respondents rated research in pharmacologic 

and biologic treatments and nutritional therapeutics for cancer treatment and symptom/side-effect 

management as high-priority areas. 

8 N C I C A M A N N U A L R E P O R T 2 0 0 8 
Practice Assessment Program 

OCCAM’s Practice Assessment Program (PAP) 

reviews retrospective and prospective data on cancer 

patients treated with alternative therapies. PAP manages the NCI Best Case Series (BCS) Program, which 

provides an opportunity for CAM practitioners to 

submit medical data regarding cancer CAM treatments used in their settings. Practitioners are asked 

to submit patient records for evaluation by experts 

in clinical assessment and cancer treatment research. 

Results of the NCI BCS Program are used to inform 

decisions regarding NCI-initiated research and to 

share well-documented best cases with interested 

members of the scientific community in order to 

stimulate research. 

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 Web site (http://www.cancer. 

gov/cam) and publications. 

This program also assesses the opinions, 

interests, and informational needs of cancer 

researchers, CAM practitioners, and cancer patients 

regarding CAM research through surveys, public 

comment sessions, and focus groups. Results from 

these explorations are used to guide outreach efforts 

to these communities. 

COP also developed the following publications 

in FY 2008: 

• NCI’s Annual Report on Complementary and 

Alternative Medicine: Fiscal Year 2007 

• NCI CAM News – Spring 2008 

• NCI CAM News – Fall 2008 

National Institutes of Health Yoga Week 

In FY 2008, OCCAM’s COP partnered with 

the National Heart, Lung, and Blood Institute; the Office of Research Services; the National Center for Complementary and Alternative Medicine (NCCAM); and the National 

Institutes of Health (NIH) Recreation and 

Welfare Association to host NIH’s first annual Yoga Week. The five-day series of events 

took place May 19-23, 2008 and highlighted 

the science and practice of yoga. The events 

were planned to serve NIH employees and the 

public, allowing participants to learn about 

the benefits of yoga and experience them 

first-hand through stretching and poses. 

Yoga week included presentations by 

leading yoga instructors, lectures by current 

NIH grantees conducting research on yoga, 

including Dr. Lorenzo Cohen, director of the 

Integrative Medicine Program at the University of Texas M.D. Anderson Cancer Center, and a discussion of NCI’s yoga research 

portfolio by OCCAM Director Dr. Jeffrey 

D. White. Yoga classes were taught by local 

instructors throughout the week. 

Some participants brought donations 

of non-perishable foods for Manna Food 

Center in Rockville, Maryland and the Safra 

Family Lodge at NIH. Lectures and practice 

sessions at facilities outside of NIH’s main 

campus in Bethesda, Maryland (Rockledge I 

and II and 6001 Executive Blvd., in Rockville) 

allowed off-campus NIH staff to experience 

yoga. 

O F F I C E O F C O M P L E M E N TA RY A N D A LT E R N AT I V E M E D I C I N E 9 
In addition, COP expanded OCCAM’s outreach 

efforts through exhibiting or sending publications 

to numerous professional meetings during FY 2008: 

• Society for Integrative Oncology International 

Conference – November 2007 

• Evidence-based CAM for Cancer Patients – 

January 2008 

• Oncology Nursing Society – May 2008 

• American Association of Naturopathic Physicians/ 

American Holistic Medical Association Annual 

Meeting – August 2008 

• Fourth International Conference on Holistic Health 

and Medicine – September 2008 

Working with Advocates 

In FY 2008, cancer patient advocates were involved 

in the review of NCI’s CAM Annual Report. COP 

solicited feedback from four Consumer Advocates 

in Research and Related Activities (CARRA) members who agreed to review a draft of the FY 2007 

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. Feedback 

from CARRA members improved the quality of 

the NCI’s Annual Report on Complementary and 

Alternative Medicine: Fiscal Year 2007. 

Cancer CAM Researchers Directory 

In FY 2008, COP launched OCCAM’s searchable 

directory of cancer CAM researchers. This resource 

assists researchers in this growing field to identify 

others with similar or related research interests. In 

order to be included in the online directory, researchers must register and demonstrate that they 

have published original research on a cancer and 

CAM topic by providing a literature citation. Once 

registered, users have full access to information provided by other registered users. The Cancer CAM 

Researcher Directory is located online at http:// 

www.cancer.gov/cam/research_directory.html 

OCCAM Highlights 

United States and China Accord on 

Traditional Chinese Medicine 

On July 16, 2008, the U.S. Department of Health 

and Human Services and the Chinese Health 

Ministry signed a Memorandum of Understanding 

(MOU) agreement to foster collaboration between 

researchers studying integrative and Traditional 

Chinese Medicine (TCM) in both countries. The 

MOU follows an earlier agreement, signed in 2006, 

between NCCAM and the Chinese Ministry of Science and Technology. The new agreement encompasses a much larger number of interested institutions in the United States, including NCI, and those 

in China. 

The 2008 MOU on TCM was signed at the 

beginning of a two-day research roundtable held at 

NIH that highlighted research in areas of TCM and 

displayed examples of opportunities for future collaborations between U.S. and Chinese researchers. 

The presenters discussed diagnostic approaches that 

might help identify subgroups of cancer patients 

with different reactions to conventional treatments, 

as well as quality control of herbal medicines and 

how to standardize herbal approaches in a way that 

would make research results more reproducible. 

10 N C I C A M A N N U A L R E P O R T 2 0 0 8 
CAM Researchers and 

Practitioners Conference 

In October 2007, OCCAM hosted the conference, 

Cancer Researchers and CAM Practitioners: 

Fostering Collaborations; Advancing the Science, 

to bring together people who work in a myriad 

of varying fields of cancer research, ranging from 

apoptotic cancer cells to acupuncture. The goal 

of the conference was to facilitate one of the most 

important factors in science– teamwork. 

OCCAM has long recognized that building 

and sustaining strong interdisciplinary partnerships 

is a critical factor in the success of some cancer 

CAM research endeavors. To promote this, OCCAM Director Dr. Jeffrey D. White and his staff organized the two-day conference at the NIH Natcher 

Conference Center for over 100 participants from 

around the world. Conference sessions included 

“Developing CAM for Cancer: U.S. Regulations,” 

“Understanding and Designing Clinical Case Reports,” and “Research Basics and Training Opportunities for CAM Practitioners.” 

Videocasts from the conference are archived 

at http://www.cancer.gov/cam/news_occamconferences.html. 

OCCAM’s Participation at Major 

Professional Conferences 

OCCAM staff members are active in both domestic 

and international professional conferences through 

presentations and engaging in dialog with cancer 

CAM researchers, practitioners, and patient advocacy 

groups. 

During FY 2008, this encompassed several important 

meetings: 

• Drs. Jeffrey D. White and Libin Jia attended the 

International Traditional Chinese Medicine Conference for Cooperation in Science and Technology in 

Beijing, China, November 28-29, 2007. 

• Dr. Jeffrey D. White attended the 3rd International 

Congress on Complementary Medicine Research in 

Sydney, Australia, March 29-31, 2008. 

• Dr. Libin Jia participated in an “NCI Meet the 

Experts” session during the American Association 

of Cancer Research meeting in San Diego, CA, April 

12-16, 2008. 

• Drs. Jeffrey D. White and Dan Xi attended the Society of Integrative Oncology’s Shanghai International 

Symposium: Integrative Oncology Theory, Research, 

and Practice in China, April 25-26, 2008. 

• Ms. Lauren Rice attended the National Conference 

on Health Communication, Marketing, and Media 

in Atlanta, GA, August 12-14, 2008. 

• Dr. Oluwadamilola Olaku presented at the Research 

Working Group on Case Reports in Heidelberg, 

Germany, September 5, 2008. 

• Dr. Farah Zia presented at the Insulin Potentiation 

Therapy Conference in San Diego, CA, September 

26-28, 2008. 

NCI participation at other conferences and events can 

be found in the Training and Conferences section on 

pg. 18). 

O F F I C E O F C O M P L E M E N TA RY A N D A LT E R N AT I V E M E D I C I N E 11 
OCCAM Staff List: FY 2008 

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

Christina Armstrong Administrative Program Specialist 

Akia Samuda Administrative Assistant 

April Woodfork Administrative Assistant 

Dan Xi, Ph.D. Program Officer 

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

Libin Jia, M.D. Health Scientist Administrator 

Obianuju Igbokwe, M.S. Cancer Research Training Award (CRTA) Fellow 

Shadia Kawa, M.S. CRTA Fellow 

Farah Zeba Zia, M.D. Director, Practice Assessment Program 

Colleen Lee, CDR (U.S. PHS), M.S., 

CRNP, AOCN® Coordinator, Practice Assessment Program 

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

Lauren Rice, M.S. Communications Analyst 

Jennifer Frazier, M.P.H. Health Communications Intern 

Vera Rosenthal, M.P.H. Health Communications Intern 

12 N C I C A M A N N U A L R E P O R T 2 0 0 8 
NCI CAM 

Communications Programs 

NCI directs communications programs that are committed to 

providing current and credible information resources about 

CAM to its stakeholders. 
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®), NCI’s comprehensive cancer 

database. PDQ produces a registry of clinical trials 

and summaries covering topics such as cancer treatment, prevention, screening, and CAM. 

Most Frequently Accessed 

PDQ CAM Summaries 

NCI tracks of the number of page views for both 

patient and health professional versions of each 

PDQ CAM summary on Cancer.gov. The number of page views is determined by the number of 

views/visits to the first page of each PDQ summary. 

In FY 2008, the patient version summary 

with the highest number of page views was Coenyzme Q10, with 30,163 page views. The second 

highest number of page views was for the patient 

version of Essiac/Flor-Essence, with 25,581 page 

views. Third in the rankings was the Mistletoe 

patient summary, with 18,442 page views. 

Note: NCI’s 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 2. PDQ CAM Summaries 

Patient summary page views 

714X Acupuncture Antineoplastons Aromatherapy Cancell/Entelev Cartilage Coenzyme Q10 Essiac/Flor-Essence Gerson Therapy 

Totals 4242 11596 2663 8306 3725 9347 30163 25581 10885 

Health professional summary page views 

714X Acupuncture Antineoplastons Aromatherapy Cancell/Entelev Cartilage Coenzyme Q10 Essiac/Flor-Essence Gerson Therapy 

Totals 1772 3871 2055 4581 1334 2067 5743 3932 2451 

14 N C I C A M A N N U A L R E P O R T 2 0 0 8 
During FY 2008, the highest number 

of page views received for a health professional 

version of a PDQ CAM summary was 6,997 for 

Mistletoe. Coenzyme Q10 had the second most 

page views for a health professional version with 

5,743 page views. The Aromatherapy professional 

summary, with 4,581 page views, had the third 

most page views. 

Figure 2 shows the total number of page 

views during FY 2008 for all of the PDQ CAM 

summaries. 

PDQ CAM Clinical Trials 

NCI sponsors clinical studies on CAM approaches for cancer. On the OCCAM Web site, 

there is a table which organizes CAM clinical 

trials by cancer types and types of symptoms. 

Clicking on an entry in the table triggers a search 

of NCI’s PDQ Cancer Clinical Trials Registry, 

which includes abstracts of approximately 4,500 

protocols that are open and approved to accept patients as well as trials that are closed. 

The Registry is available on the NCI Web site at 

http://www.cancer.gov/clinicaltrials/search/. 

In FY 2008, there were 111 cancer CAM clinical 

trials. (See appendix on page 67 for the complete 

list.) 

For the current list of CAM clinical trials 

by cancer type and to access the CAM clinical 

trials table, go to http://www.cancer.gov/cam/ 

clinicaltrials_list.html. 

The NCI fact sheet “Complementary and Alternative Medicine in Cancer Treatment: 

Questions and Answers” was viewed 23,981 times in FY 2008. To view this publication, 

please visit http://www.cancer.gov/cancertopics/factsheet/therapy/cam.

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

Disease Virus 

PC-SPES Selected Vegetables/ 

Sun’s Soup 

Spirituality in 

Cancer Care 

3158 6007 18101 11972 18442 5255 5670 479 6174 

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

Disease Virus 

PC-SPES Selected Vegetables/ 

Sun’s Soup 

Spirituality in 

Cancer Care 

2071 1084 2988 3459 6997 2014 3193 152 7581 

N C I C A M C O M M U N I C AT I O N S P R O G R A M S 15 
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 with cancer, and consumers. 

NCI’s Annual Reports on CAM 

OCCAM published NCI’s Annual Report on 

Complementary and Alternative Medicine: Fiscal 

Year 2007, 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/CAM 

AnnualReportFY2007.pdf. 

In FY 2008, NCI’s Annual Report on 

Complementary and Alternative Medicine: Fiscal 

Year 2006 was selected from over 2,300 entries for 

the RX Club Award of Excellence. The NCI CAM 

report was displayed at the 22nd Annual RX Club 

Show. The RX Club honors the creative aspects 

of healthcare product advertising and promotion, 

provides an independent forum for the worldwide 

healthcare advertising community to exchange 

ideas, showcases their best creative projects, and 

brings forth innovative ideas in the expanding 

healthcare market place. 

Newsletter on NCI’s CAM Activities 

OCCAM’s 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. 

The following issues of NCI CAM News 

were made available online during FY 2008: 

• Spring 2008 

http://www.cancer.gov/cam/newsletter/ 

2008-spring/home.html 

• Fall 2008 

http://www.cancer.gov/cam/newsletter/ 

2008-fall/home.html 

16 N C I C A M A N N U A L R E P O R T 2 0 0 8 
CAM in NCI Newsletters and Publications 

The NCI Cancer Bulletin is a biweekly online newsletter designed to provide useful, timely information 

about cancer research to the cancer research community. During FY 2008, numerous cancer CAM 

studies were featured in the NCI Cancer Bulletin: 

• Probing the Effects of Circadian Rhythms on 

Cancer (February 19, 2008) 

• Herbal Therapy for Brain Cancer (April 15, 2008) 

• Vitamin D Not Associated with Decreased Prostate Cancer Risk (May 27, 2008) 

• Vitamin C Injections Slow Tumor Growth in 

Mice (August 19, 2008) 

Likewise, in FY 2008, cancer CAM was the topic of 

stories in other NCI and NIH publications: 

• Liver Cancer Chemoprevention Trial, DCEG 

Linkage (March 2008) 

• Vitamin D and Cancer Mortality, DCEG 

Linkage (March 2008) 

• Red and Processed Meat Intake, DCEG 

Linkage (March 2008) 

• NCI Collaborates with China on Esophageal 

Cancer Research, DCEG Linkage (March 

2008) 

• Visiting Scholar Mimi Yu, DCEG Linkage 

(March 2008) 

• NIH Marks First Annual Yoga Week, NIH 

Record (June 13, 2008) 

• Mediterranean Diet in a U.S. Population, 

DCEG Linkage (July 2008) 

• Effects of Physical Activity, DCEG Linkage 

(July 2008) 

• Amanda Cross Investigates Red Meat and 

Cancer Risk, DCEG Linkage (July 2008) 

• The Natural Products Repository: 

A National Drug Development Resource, 

CCR Connections (Volume 2, No. 2, 2008) 

• The Mediterranean Diet Reduces the Risk of 

Dying from Chronic Diseases, Diet and Health 

Study News, NIH-AARP (Fall 2008) 

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 via phone, live online chat, mail, and 

e-mail to answer questions about cancer treatment and clinical trials, including CAM therapies. During FY 2008, CIS responded to 1,493 

inquiries regarding CAM approaches for cancer 

prevention and treatment. 

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. 

N C I	� C A M C O M M U N I C AT I O N S P R O G R A M S 17 
Training and Conferences 
NCI provides an array of training support programs on 

aspects of CAM research including grant writing work 

shops and scientific conference sponsorships. 
Training Opportunities at OCCAM 

During FY 2008, OCCAM hosted two CRTA fellows, Ms. Obianuju Igbokwe, M.S. and Ms. Shadia 

Kawa, M.S., who were mentored by Dr. Jeffrey D. 

White, OCCAM director. The fellows’ goals were 

to learn about the NIH grant process and explore 

approaches to cancer CAM research. During the 

course of the fellowship, the CRTAs assisted with 

tasks including coding the CAM modality for projects in the NCI CAM research portfolio, providing 

support to the OCCAM programs, and working on 

literature review projects that may be submitted for 

publication. 

In addition, OCCAM also hosted two 

Health Communications Interns, Ms. Jennifer Frazier, M.P.H., and Ms. Vera Rosenthal, M.P.H., who 

were mentored by Ms. Shea Buckman, M.A., coordinator of the COP. The interns helped organize 

and execute a scientific conference, write articles 

for the newsletter NCI CAM News, write and edit 

publications and other promotional materials, and 

assisted with the management of OCCAM’s Web 

site. These interns also participated in professional 

meetings and NIH-sponsored training seminars. 

CAM Researcher Honored 

Dr. Jie Li, a visiting postdoctoral fellow in NCI’s 

CCR was honored with the Outstanding Poster 

Presentation Award for his presentation – 

“Inhibitory Effect of Sheng Qi Formula on 

Gr-1+CD11b+ Myeloid Immunosuppressor Cells in 

the 4T1 Murine Mammary Cancer Model” – 

at the Eighth Annual NCI/CCR Fellows and 

Young Investigators Colloquium on March 3, 2008. 

Dr. Li’s research was supported by OCCAM, NCI’s 

Laboratory of Molecular Immunoregulation, and 

the Office of International Affairs as part of a collaboration with Guang An Men Hospital, a component of the China Academy of Chinese Medical 

Sciences in Beijing. 

NCI Lectures and Workshops on CAM 

NCI provides educational opportunities for its 

scientific program staff, fellows, other staff 

members, and the public on topics related to cancer. 

In FY 2008, the following seminars and lectures 

relevant to CAM research were held: 

Division of Cancer Prevention 

Stars in Nutrition & Cancer – Genetic and 

Nutritional Modulation of Intestinal Tumorigenesis 

October 4, 2007 

http://prevention.cancer.gov/newsandevents/ 

eventsarchive/20071004 

Intestinal Homeostasis, Inflammation and 

Neoplasia: Dietary Chemoprevention Strategies 

February 13, 2008 

Frontiers in Cellular Energetics, Diet and 

Cancer Prevention 

March 12, 2008 

http://prevention.cancer.gov/CEDCP 

20 N C I C A M A N N U A L R E P O R T 2 0 0 8 
T R A I N I N G A N D C O N F E R E N C E S 21 

Nutrition and Cancer Prevention 

Research Practicum 

March 17-21, 2008 

http://prevention.cancer.gov/newsandevents/ 

eventsarchive/20080317-21 

Nutrition and Cancer: From Genotype to 

Phenotype 

March 18, 2008 

http://dcp.cancer.gov/newsandevents/ 

eventsarchive/20080318 

Cancer Prevention: Discovery and 

Development of Ethnobotanicals 

from the Developing World 

May 14, 2008 

http://dcp.cancer.gov/newsandevents/ 

eventsarchive/20080514 

Division of Cancer Control and 

Population Sciences 

Biobehavioral Influences on Tumor Biology: 

Preclinical Models of Neuroendocrine Regulation 

June 24-26, 2008 

http://guest.cvent.com/EVENTS/Info/Summary. 

aspx?e=08625354-009b-4ff5-a902-8e8efe9eea1b 

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 fifty-minute presentation on a cancer 

CAM topic and allow 10 minutes for questions. 

The lectures are open to the public and also are 

archived as videocasts on the OCCAM Web site at 

http://www.cancer.gov/cam/news_lectures.html. 

During FY 2008, the series included the following 

lectures on: 

• Endothelial Lineage Cells in Cancer: A Potential 

Target for Green Tea Derived Catechins 

• Bringing Evidence to CAM Approaches for 

Supportive Care in Children with Cancer 

• Why and How to Globalize Traditional 

Chinese Medicine: A Case Study Looking at the 

Potential of PHY 906 as an Effective 

Anti-cancer Adjuvant Therapy 

• Personalized Phytococktail for the Management 

of Prostate Cancer 

• A Pilot Trial of Acupuncture for Cancer-related 

Fatigue: Lessons Learned 

• Effects of Phytochemicals on Prostate Cancer 

Stem Cells 

• The Deconstruction of Ginseng – What is the 

Sum of Its Parts in Breast Cancer Treatment? 

• Omega-3 Fatty Acids and Ovarian Cancer 

• Curcumin Suppression of Head and 

Neck Cancer 

• Energy Medicine Research in an 

Oncology Setting 
Support of Scientific Conferences 

In FY 2008, NCI helped financially support the following conferences, all of which included CAM-related content. 

Conference Title Date Location Grant Number 

American Association for Cancer 

Research-Transdisciplinary Research on 

Energetics and Cancer-National Institutes 

of Health Think Tank Conference: 

Energy Balance and Cancer; 

Mechanism and Mediators 

February 24-26, 2008 Lansdowne, VA 1R13CA134016-01 

Gordon Research Conference on 

Marine Natural Products 2008 

February 24-29, 2008 Ventura, CA 1R13CA132218-01 

14th Biennial Federation of American 

Societies for Experimental Biology (FASEB) 

Summer Research Conference 

on Retinoids 

June 15-20, 2008 New Haven, CT 1R13DK081216-01 

Molecular Mechanisms Involved in the 

Nutrient Control of Cellular Function 

and Metabolism 

July 20-25, 2008 Carefree, AZ 5R21DK071458-04 

FASEB Summer Conference: Folic Acid, 

Vitamin B12, and One Carbon 

Metabolism 

August 10-15, 2008 Il Ciocco, Italy 5R13DK076513-03 

FASEB Summer Research Conference 2008- 

Melatonin Receptors: Actions 

and Therapeutics 

August 15-18, 2008 Snowmass, CO 1R13NS063489-01 

2008 International Symposium 

(joint meeting of the Eighth International 

Skin Carcinogenesis Conference and the 

Third International Hormel Institute 

Frontiers in Cancer Research Symposium) 

October 4-7, 2008 Austin, MN 1R13CA135806-01 

33rd Annual Conference of the American 

Society of Preventative Oncology 

March 8-10, 2009 Tampa, FL 2R13CA094927-07 

Society of Behavioral Medicine Annual 

Meeting and Scientific Sessions 

April 22-25, 2009 Montreal, Canada 5R13CA091918-08 

North American Research Conference on 

Complementary and Integrative Medicine 

May 12-15, 2009 Minneapolis, MN 1R13AT005049-01 

Annual Mentoring Program in PsychoNeuroImmunology Research 

May 28-31, 2009 Madison, WI 1R13CA134006-01 

6th International Conference of the 

Society for Integrative Oncology 

November 12-13, 2009 New York City, NY 7R13CA126426-03 
Bioactive Food and Chemoprevention 

Symposium Held in FY 2008 

The first-ever, international symposium on 

“Bioactive Food Components, Alternative 

Medicine, and Cancer Chemoprevention,” 

held in Greece in October 2007, was supported, in part, by an FY 2007 R13 conference grant* from OCCAM and NCCAM. 

The two-day meeting drew almost 150 

attendees and included presentations and 

discussions on recent advances in the field 

including studies on prostate cancer chemoprevention with genistein and resveratrol, 

anti-inflammatory and antioxidant agents 

present in dietary and medicinal plants, 

and recent advances in mechanisms of 

cancer chemoprevention by grape seed 

extract. 

John Milner, Ph.D., chief of NCI’s 

Nutritional Sciences Research Group, 

delivered a presentation on “Frontiers in 

Cancer Prevention by Bioactive Food 

Components.” Dr. Milner also co-chaired 

the symposium’s opening session with conference organizer Shivendra Singh, Ph.D., 

professor at the University of Pittsburgh 

School of Medicine and co-leader of the 

Cancer Biochemoprevention rogram at 

the University of Pittsburgh Cancer 

Institute. The grant from OCCAM and 

NCCAM helped partially cover travel 

costs of the organizers, invited speakers, 

and young investigators, as well as pay for 

publicity for the meeting. Papers from the 

conference will be published in Nutrition 

and Cancer. 

*Grant Number: 1R13CA132241-01 

T R A I N I N G A N D C O N F E R E N C E S 23 
Highlights from NCI’s 

CAM Training Projects 
The highlights on the following pages are selected from 

the 32 CAM training projects that NCI supported during 

FY 2008 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 con 

trol research of CAM therapies and interventions. 

Abstracts for the CAM training projects featured 

in the report can be found by searching the NIH RePORTer 

database at http://projectreporter.nih.gov/reporter.cfm. 
Nurses Trained to 

Do Presurgery Hypnosis for 

Breast Cancer Patients

Cancer Training Branch 

Nurse anesthetists in two different hospital settings are being trained to perform a brief hypnosis 

intervention for breast cancer patients just prior 

to surgery. In an earlier clinical study*, the technique had been shown to reduce pain, nausea, and 

fatigue in a sample of 200 breast cancer surgical 

patients. The benefits of hypnosis also resulted in a 

cost savings for the institution of $772 per patient. 

“Based on those findings, we asked ourselves, how do we get this beneficial technique out 

to more people beyond the academic medicine setting?” noted Principal Investigator Guy H. Montgomery, Ph.D., associate professor and director of 

the Integrative Behavioral Medicine Program at 

Mount Sinai School of Medicine in New York City. 

“We thought one way would be by working with 

nurses. They’re in the clinical setting and directly 

involved in symptom control and management, so 

they are a good way to get this to patients in the 

‘real world’.” 

Funded by an NCI Cancer Education 

grant,** Dr. Montgomery and his colleagues are 

conducting and evaluating a research dissemination 

program to train more than 25 nurses at Mt. Sinai 

Medical Center – a private research and teaching 

hospital – and also at Kings County Hospital, a 

public hospital in Brooklyn. “We believe that it is 

important to disseminate information on this kind 

of intervention so it is not just being offered to 

patients coming to private hospitals like Mt. Sinai. 

We’re also trying to get it out there to public 

hospital patients, as well,” he noted. 

The nurses receive four training sessions on 

the 15-minute hypnosis technique, using role play 

and feedback. They are also provided with journal 

articles, information about hypnosis, and data on 

its effectiveness in the clinical setting. “They love 

doing the intervention,” Dr. Montgomery reported. 

“It’s been a learning curve for us in finding out 

how can we fit the training program into nurses’ 

busy schedules and make sure that people get the 

information they need.” 

Over the next three years, the researchers 

will study the impact of the hypnosis intervention 

on patient outcomes and institutional costs. “It’s 

a simple intervention that people can easily adopt 

and that can potentially have large benefits, both 

for the patients in symptom reduction and for 

institutions and society at large,” Dr. Montgomery 

said. 

*Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A 

randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. Journal of the National Cancer Institute, September 5, 2007; 99(17):1304-12. Epub August 28, 2007. 

**Grant Number: 5R25CA129094-02 

26 N C I C A M A N N U A L R E P O R T 2 0 0 8 

Psychologist Helps 

Breast Cancer Patients 

Cope with Radiation Treatment

Cancer Training Branch 

Clinical psychologist Julie B. Schnur, Ph.D., is using an NIH Career Development Award* to study 

a promising cognitive-behavioral therapy (CBT) in 

combination with hypnosis to help breast cancer 

patients deal with the pain and emotional distress 

from skin damage caused by radiation treatment. 

“I’ve always been interested in working with 

cancer patients,” noted Dr. Schnur who is an assistant professor in the Department of Oncological 

Sciences, Integrative Behavioral Medicine Program, 

at the Mount Sinai School of Medicine in New York 

City. Her first research project as an undergraduate 

was a qualitative study on childhood cancer survivors and their parents and the predictors of PTSD 

(post-traumatic stress disorder). She continued to 

pursue cancer research through her post-doctoral 

fellowship at Mount Sinai. “It’s a great experience to 

be able to continue to learn more about research and 

also use my clinical skills interacting with patients,” 

she said. 

Dr. Schnur worked with her post-doctoral 

mentor Guy Montgomery, Ph.D., on his study of 

the CBT/hypnosis intervention to treat fatigue in 

breast cancer patients (see related story, page 26). 

Dr. Montgomery told her about the NIH career 

award program. “As I was talking with these patients about fatigue, they also started talking to me 

about the radiation-induced skin changes, how ugly 

they felt, how it interfered with their sleep, and how 

it hurt,” she recalled. Finding little information about 

the problem in medical literature, Dr. Schnur applied 

for the NIH grant to test the CBT/hypnosis method 

to combat the effects of acute skin toxicity in patients 

undergoing radiation. 

The CBT involves teaching patients to identify negative thoughts and learn how to “debate” 

those thoughts – to ask themselves if negative thinking is helping them or causing them more stress – 

and helping the patients to exchange those thoughts 

for more helpful, positive thoughts. In twice-weekly 

sessions with the patients, Dr. Schnur discusses their 

CBT workbook entries and conducts brief hypnosis 

sessions to provide suggestions to reduce their overall 

stress levels and focus on coolness, “because the skin 

damage can feel like a burn”, as well as healing, 

reduced pain, and comfort. 

She has completed the initial qualitative 

phase of the study, interviewing 20 breast cancer 

patients to develop a better description of the skin 

problems related to radiation toxicity. Dr. Schnur 

plans to enroll 144 women into a randomized clinical trial of CBT/hypnosis compared to a control 

group of patients who will receive non-therapeutic, 

twice-weekly consultations with her. 

If the intervention proves effective, it could 

be a “terrific complement to current medical treatments for these patients,” Dr. Schnur said. “All of the 

distress and psychological reactions to this problem 

aren’t dealt with by a purely medical approach.” 

*Grant Number: 1K07CA131473-01 

28 N C I C A M A N N U A L R E P O R T 2 0 0 8 

Expressive Writing Program May Help 

Advanced Breast Cancer Patients 

Cancer Training Branch 

Often patients with advanced breast cancer receive 

relatively little support in dealing with the serious 

psycho-social concerns they face from their growing dependence on others, cognitive and physical 

decline, and issues related to the end-of-life. Teaching 

these patients to write expressively and disclose their 

deepest thoughts and feelings about their condition 

may reduce their emotional and physical distress by 

providing them opportunities to share their cancer 

experiences and find meaning in their situations. 

Clinical psychologist Catherine E. Mosher, 

Ph.D., was awarded an NIH fellowship grant* to 

study the impact of an expressive writing program 

on women with metastatic breast cancer. “There was 

a study in metastatic, renal-cell carcinoma patients 

where they found expressive writing had sleep-related health benefits,” noted Dr. Mosher, a postdoctoral 

research fellow at Memorial Sloan-Kettering Cancer 

Center Department of Psychiatry & Behavioral 

Sciences. “I wondered if I could replicate that finding 

in breast cancer patients.” 

She is well on the way to enrolling 98 patients 

in the study, which will compare the expressive writing method against a control group of patients who 

will write only about their daily activities. 

Dr. Mosher conducts four weekly phone sessions 

with each patient. “I call them on the phone and 

ask them to write about their moods,” she reported. 

Women in the expressive writing group use a workbook to “write about their deepest thoughts and 

feelings regarding their cancer experience,” she 

explained. 

“I strongly believe that home-based interventions like this are needed, particularly for advanced 

cancer patients,” Dr. Mosher added. “Not all of 

them can travel to hospitals for group or individual 

therapy sessions.” 

The study will primarily assess the impact of 

expressive writing on the patients’ levels of distress 

(i.e., depressive symptoms and feeling disheartened). 

It will also monitor effects on other outcomes, 

including a sense of meaning in life and peace, pain 

severity, sleep disturbance, fatigue, and functional 

impairment. 

Dr. Mosher heard about the NIH fellowship program during her doctoral health psychology 

internship at Duke University Medical School. 

She successfully applied to the program and has 

found it “a tremendous opportunity to collaborate 

with multiple laboratories, to mentor student volunteers who help with my study, and to write grant 

proposals. It’s been a really good two years.” 

*Grant Number: 5F32CA130600-02 

30 N C I C A M A N N U A L R E P O R T 2 0 0 8 

Career Mentors Bring Young 

Investigator into Promising Skin Cancer 

Prevention Work

Cancer Training Branch 

Native Americans in the Southwest call Arizona the 

“land of the endless sky,” yet out of that sky rains 

a continuous stream of UVB radiation. This type of 

radiation causes DNA damage that can lead to nonmelanoma skin cancer, the most common cancer in 

the United States accounting for almost two in every 

five cancer diagnoses. 

David Alberts, M.D., director of the Arizona Comprehensive Cancer Center (ACCC) at the 

University of Arizona (UA), and his colleagues G. 

Timothy Bowden, Ph.D., deputy director, and Steve 

Stratton, Ph.D., drug development core leader, are 

all renowned researchers in the field and work as 

co-investigators on a Skin Cancer Program Project 

grant from the NCI. Part of their leadership includes 

mentoring young investigators that come to work in 

Tucson, such as Sally Dickinson, Ph.D. 

“That’s part of what is so great about the 

ACCC,” Dr. Dickinson said. “There are about 35 

post-docs working here, and we enjoy a high level 

of access to training and support systems both at 

the Cancer Center and throughout UA as a whole. 

The support from and contact with senior investigators is a priority, and so we benefit from a lot of 

valuable networking.” 

Dr. Dickinson has just received her research 

assistant professorship at UA and is focusing on 

sulforaphane – a bioactive ingredient in cruciferous 

vegetables such as broccoli and cauliflower – which 

Dr. Bowden’s lab is actively investigating as a cancer 

preventive agent. “One of the standard explanations 

for sulforaphane’s early experimental success has 

been activation of the Nrf2 gene,” Dr. Dickinson 

explained. Nrf2 is widely accepted as an essential 

transcription factor in protecting humans from oxidative stress-related diseases including UVB-induced 

damage. 

This path from graduate student to assistant 

professor and cancer biologist at UA has been aided 

by Dr. Dickinson’s receipt of a Career Development 

Award (K07 grant) from NCI.* She has been aided 

by a team of outstanding mentors at ACCC in skin 

cancer research, mouse studies, drug formulation, 

bioethics, biostatistics, and clinical trial management. 

“Moving into the active community of researchers looking at sulforaphane is really exciting,” 

Dr. Dickinson noted, while mentioning contacts and 

discussions she had at the 2009 annual meeting of 

the American Association for Cancer Research. “We 

think sulforaphane is a powerful agent with potential 

for the prevention of cancers in many other tissues as 

well as skin,” she added. “I think the NCI award has 

opened up the path for me to investigate what looks 

like a truly vital opportunity in cancer prevention.” 

*Grant Number: 1K07CA132956-01A1 

32 N C I C A M A N N U A L R E P O R T 2 0 0 8 

NCI Research in Complementary 

and Alternative Medicine 
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 OC 

CAM is responsible for gathering the data needed to report 

the total CAM expenditures budget figure each year. 

It is a common misconception that OCCAM man 

ages all of the CAM projects for NCI. The vast majority of 

CAM projects are managed by other programs and labora 

tories throughout the Institute. After the close of the fiscal 

year, NCI’s Division of Extramural Activities provides OC 

CAM with a list of funded grants and cooperative agreements 

that were coded as containing some component of CAM re 

search. Similarly, NCI’s two intramural components, CCR 

and DCEG, provide lists of their potentially relevant projects. 

Also, a list of contracts identified as potentially containing 

CAM research is provided. OCCAM reviews each project 

to confirm those projects which are accurately classified as 

CAM research. OCCAM also classifies each CAM project into 

a sub category to further define the purpose of the research. 

NCI’s total CAM expenditure figure includes money 

awarded for intramural projects (projects conducted with 

in NIH facilities and labs), extramural grants, cooperative 

agreements, contracts, and supplements. It is important to 

note that the reported figure for total NCI CAM expenditures 

for a fiscal year does not include projects for which NCI is not 

the primary funder. 

N C I R E S E A R C H I N C O M P L E M E N TA R Y A N D A LT E R N AT I V E M E D I C I N E 37 

NCI CAM Research 

Portfolio Analysis: FY 2008 

Total Estimated Cancer 

CAM Research Expenditure 

In FY 2008, NCI invested $121,264,507 for 

444 intramural and extramural research 

projects relevant to CAM. For the purpose of the 

FY 2008 analysis, the following types of funding 

are included: intramural projects and extramural 

grants, cooperative agreements, contracts, and 

supplements. (See Figure 3.) 

For the first time in this annual report, the 

portfolio analysis includes CAM training grants, 

both training (T) and fellowship (F) awards, as well 

as career (K) and cancer education (R25) grants listed 

in Figure 4. 

Grant Awards by Funding 

Opportunity Announcement 

In FY 2008, there were 70 funding opportunity announcements (FOA) that yielded cancer CAM 

grants. The program announcement 

“Research Project Grants/Parent R01” (PA-07-070) 

was the most productive mechanisms for attracting 

new CAM grants to NCI. A total of 36 of the 210 

CAM grants awarded through FOAs in FY 2008 

came to NCI through this announcement. 

(See Figure 5.) 

Project Distribution 

by Research Type 

The accompanying pie-chart (Figure 6) shows the 

distribution of the projects according to research 

type: prevention, treatment, symptom/side effects 

management, epidemiology, and conferences. 

In FY 2008, 60.9% of cancer CAM-related research 

project funds went to various cancer prevention 

efforts, while treatment, symptom/side effects management, epidemiology, and conferences received 

20.7%, 10.6%, 7.8%, and 0.05% respectively. 

Figure 3. NCI CAM Expenditures: FY 2003-2008 

Millions 

$121,264,507

$130 

$128 

$126 

$124 

$122 

$120 

$118 

$119,900,00

$128,671,113

$121,076,919

$123,076,167

$121,832,765

2003 2004 2005 2006 2007 2008

* Footnote: 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) Total projects include all active projects in FY 2008. 
Figure 4. NCI CAM Training Projects 

Training Grant Mechanisms Number of Grants Total Funding 

F (31, 32) 4 $ 112,679 

K (01, 05, 07, 22, 23, 24) 20 $1,627,828 

R25 5 $ 753,054 

T32 3 $ 188,753 

TOTAL 32 $2,682,314 

Figure 5. Number of Grant Awards by Funding Opportunity Announcement 

*AT03-002 2 

*CA02-007 1 

*CA03-001 3 

*CA03-003 6 

*CA03-006 1 

*CA04-001 1 

*CA04-002 1 

*CA04-004 6 

*CA04-008 1 

*CA05-013 2 

*CA05-014 1 

*CA07-025 6 

*ES02-009 1 

*ES05-007 1 

*OD03-008 1 

PA02-001 1 

PA04-046 1 

PA04-053 8 

PA04-068 1 

PA04-099 2 

PA04-108 2 

PA05-027 1 

PA05-040 1 

PA05-059 1 

PA05-125 2 

PA05-141 1 

PA06-041 1 

PA06-042 1 

PA06-120 1 

PA06-283 1 

PA06-303 3 

PA06-314 1 

PA06-315 5 

PA06-351 2 

PA06-400 6 

PA06-412 3 

PA06-413 2 

PA06-414 2 

PA06-440 1 

PA06-510 7 

PA07-007 2 

PA07-070 36 

PA07-100 1 

PA07-174 1 

PA07-175 2 

PA07-176 1 

PA07-177 1 

PA07-257 2 

PA07-280 2 

PA07-320 1 

PA07-356 1 

PA07-362 2 

PA08-050 1 

PAR01-110 1 

PAR03-009 1 

PAR03-010 3 

PAR03-153 4 

PAR04-011 1 

PAR04-147 10 

PAR04-159 2 

PAR05-156 4 

PAR06-073 2 

PAR06-294 5 

PAR06-313 23 

PAR06-451 2 

PAR06-458 2 

PAR06-505 1 

PAR08-055 3 

PAR99-167 1 

PAS02-009 1 

Solicited 210 

Unsolicited 185 

Total 

Grants 

Awarded 395 

* Request for Applications (RFA). 

Figure 6. NCI CAM Research Projects by 

Research Type* 

Prevention 

$73,822,456 

60.9% 

Treatment 

$25,044,245 

20.7% 

Symptom/SideEffect Management 

$12,845,699 

10.6% 

Epidemiology 

$9,495,005 

7.8% 

Conferences 

$57,202 

0.05% 

* 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) Total projects include all active projects in FY 2008. 

Figure 7. NCI CAM Research Projects by CAM Category* 

71.3% 

Nutritional 

Therapeutics 

$86,484,149 

14.9% 

Pharmacological and 

Biologic Treatments 

$18,045,277 

4% 

Mind-Body 

Interventions 

$4,834,050 

.5%

Manipulative & BodyBased Methods
�

$588,738 

.6%

Alternative 

Medical Systems

$710,734 

3.4%

Exercise Therapies

$4,158,335 

.5% 

Spiritual Therapies 

$609,579 

4.7% 

Miscellaneous 

$5,722,824 

.1%

Energy Therapies

$120,821 

38 N C I C A M A N N U A L R E P O R T 2 0 0 8 
N C I R E S E A R C H I N C O M P L E M E N TA R Y A N D A LT E R N AT I V E M E D I C I N E 39 

Project Distribution by CAM Category 

In FY 2008, NCI performed or supported research 

addressing a variety of CAM therapies (Figure 7). 

These CAM therapies fall into nine groups: alternative medicine systems, exercise therapies, manipulative and body-based methods, mind-body interventions, nutritional therapeutics, pharmacological 

and biologic treatments, energy therapies, spiritual 

therapies, and miscellaneous. (See page 4 for 

definitions of CAM categories.) 

The largest percentage (71.3%) 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 according to the subcategory of nutritional therapeutics. 

Project Distribution by Cancer Type 

The research projects that make up NCI’s FY 2008 

CAM research portfolio address 19 categories of 

cancer types. Among the various categories, prostate, breast, colorectal, and lung cancers received 

the largest amounts of cancer CAM research funding. Nearly one-quarter (23%) of NCI’s cancer 

CAM research funding was allotted for “multiple 

types” of cancer within the same project. 

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 

$30,744,102 

35.5% 

Minerals 

$20,729,893 

24.0% 

Vitamins 

$19,625,975 

22.7% 

Dietary Regimens 

$5,157,278 

6.0% 

Fats 

$4,991,414 

5.8% 

Food 

$4,471,579 

5.2% 

Amino Acids and 

Proteins 

$763,908 

0.1% 

* 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) 

Total projects include all active projects in FY 2008. 

Figure 9. NCI CAM Research Projects by Cancer Type* 

Bladder $980,937 

Brain $174,424 

Breast $16,774,338 

Cervical $1,364,913 

Childhood $238,184 

Colorectal $15,377,660 

Esophageal $871,533 

Gastric $1,731,659 

Head and Neck $2,884,084 

Hematologic $1,285,793 

Kidney $35,556 

Liver $579,474 

Lung $13,500,476 

Multiple Types $27,973,073 

Ovarian $322,882 

Pancreatic $3,807,957 

Prostate $25,723,501 

Skin: Non-Melanoma and Melanoma $7,561,560 

Small Intestines $76,503 

TOTAL: $121,264,507 

* 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) Total projects 

include all active projects in FY 2008. 
Highlights from NCI’s 

Wide-Ranging CAM Research 
The following research highlights are selected from the 444 

CAM research projects that NCI supported during FY 2008 

at laboratories within the Institute and throughout the United 

States and the world. These research projects are organized 

under several categories reflecting NCI’s comprehensive re 

search focus into understanding the underlying mechanisms 

of cancer causation, prevention, treatment, and symptom 

management and palliation of the disease. 

Abstractsfortheresearchprojectsfeaturedinthereport 

can be found by searching the NIH RePORTer database at 

http://projectreporter.nih.gov/reporter.cfm. 
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.
Understanding the Causes and Mechanisms of Cancer 

Chickens Studied for Ways to 

Prevent and Detect Ovarian Cancer

Division of Cancer Prevention 

Ovarian cancer is known as the “silent killer,” 

because researchers have been unable to 

develop a test or screening tool to reliably 

detect it in the early, more treatable stages. There has also been little progress on 

prevention of the disease. Dale Buchanan 

Hales, Ph.D., chair of the Physiology 

Department at Southern Illinois University 

School of Medicine, is trying to find ways to 

prevent or detect the disease sooner. 

With NCI funding*, Dr. Hales is continuing his research using Gallus domesticus or the common American chicken. Since publication of a landmark 

paper in 1971, the study of ovarian cancer has benefited 

from this unusual animal model, said Dr. Hales, because 

chickens develop a lot of spontaneous ovarian cancer, 

even more than humans. 

Most scientists believe this higher risk of ovarian 

cancer in domesticated chickens can be explained by the 

incessant ovulation hypothesis. “In an effort to maximize 

their egg production, farmers breed them to ovulate about 

five days out of seven,” Dr. Hales explained. “With each 

ovulation comes inflammation and oxidative stress to the 

cells of the ovarian surface epithelium (OSE), which is 

where ovarian cancers develop in hens and women.” 

Over just a few years of reproductive life, chicken hens 

ovulate up to 500 times, which is comparable to the 

number of times women ovulate over 30-40 years. 

“Women have about four weeks to recover from 

the oxidative stress and inflammation of each cycle, while 

the chicken must endure a chronic higher inflammatory load,” Dr. Hales commented. “I’m pretty sure this 

explains chickens’ high rate of ovarian cancer.” 

Based on previous research in breast cancer, 

Dr. Hales believes that ovarian cancer is also driven by 

both estrogen and cyclooxygenase-1 (COX-1) that can 

fuel OSE carcinogenesis by producing too much prostaglandin. This hormone and enzyme are essential to 

ovarian function at normal levels, but when overproduced, they can fuel unwanted cell growth. 

Researchers have known for years that fruits and 

vegetables – in particular, cruciferous vegetables such as 

cauliflower, cabbage, broccoli, and Brussels sprouts – can impede or prevent 

some cancers from developing in 

animals. Dr. Hales’ laboratory is testing whether two compounds, found 

naturally in broccoli, can interfere 

with OSE carcinogenesis in chickens. 

The first compound sulforaphane is an 

antioxidant that affects many steps in 

the development of cancer, but it cannot be 

easily produced synthetically so plant extracts 

are the primary source. 

“Testing dietary strategies always presents a challenge, because the amount of activity can vary significantly 

from plant to plant,” Dr. Hales noted. He works with the 

University of Illinois, which is producing broccoli under 

strict growth conditions and freeze dries the plants to 

get rid of the 90 percent water content. “This gives us a 

pretty reliable source of sulforaphane,” he added. 

The second compound, indole-3-carbinol (I3C), 

is another phytoactive ingredient in broccoli, which can 

be produced synthetically. “It has been studied extensively, 

and we know it increases production of enzymes 

that affect the estrogen metabolism process, and some 

that also eliminate some carcinogens from the system,” 

Dr. Hales explained. 

The researchers are feeding hens broccoli-based 

diets enriched with these two ingredients and are testing whether either compound alone, or the two together, 

has an impact on ovarian cancer. Then the researchers 

will wait to see which hens will develop ovarian cancer 

spontaneously. Dr. Hales and his colleagues also plan to 

develop ways to look at cells in the hens’ OSE as they 

begin to mutate from normal to carcinogenic. 

Because the chicken model of ovarian cancer is 

close to the human model of ovarian cancer, the tests that 

researchers are trying to develop might lead to creation 

of a cancer screening tool that could be used to look for 

early signs of ovarian cancer in the blood or urine of 

women “Ovarian cancer is not nearly as lethal when we 

catch it early, and we really need a better way to do that,” 

Dr. Hales said. 

*Grant Number: 1R03CA133915-1 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 43 
Understanding the Causes and Mechanisms of Cancer 

Physical Activity Levels 

Studied in China for Impact on Cancer Risk

Division of Cancer Epidemiology and Cancer Genetics 

A growing body of evidence demonstrates 

that the level of physical activity (PA) may 

be related to the risk of certain cancers. 

Most of these studies have been conducted in developed, urbanized Western 

societies, including the United States, but 

little is known about PA levels in China 

and other developing nations which are 

rapidly “westernizing” their economies and 

lifestyles. 

To address this knowledge gap, researchers from NCI’s DCEG have joined with scientists from 

Vanderbilt University and the Shanghai Cancer Institute 

to assess PA levels in the city of Shanghai, China. They 

are also studying how the PA habits of Chinese adults 

affect the blood plasma levels of certain inflammatory 

biomarkers associated with increased cancer risk. 

Steven C. Moore, Ph.D., a research fellow in 

DCEG’s Nutritional Epidemiology Branch noted, “We 

had epidemiologic research ongoing within Shanghai 

already, so we decided to monitor the PA of a subset of 

study participants using devices that measure motion, 

known as accelerometers.” The accelerometers provide 

researchers a minute-by-minute assessment of a participant’s physical activity. “Such data will allow us to 

examine PA at different intensity levels among men and 

women living in Shanghai and whether their PA levels are 

comparable to those of men and women in the United 

States,” he added. 

The researchers conducted their studies among 

subsets (300 individuals each) of healthy adults from the 

Shanghai Women’s Cohort and Shanghai Men’s Cohort. 

In previous work among these populations, self-reported 

data on PA levels suggested that Shanghai women engaged in much more physical activity than U.S. women, 

Dr. Moore said. Moreover, contrary to 

what has been found in the United 

States, older and/or heavier Shanghai 

residents reported a greater level of PA 

than younger and/or lighter individuals. 

Intrigued, the researchers took 

a closer look using a specially-designed 

PA questionnaire and the accelerometers, 

which each of the study participants wore 

for a full week, once every three months during the year-long study period. “One of our study 

goals was to develop a PA questionnaire that is culturally 

appropriate to China, so that we could better understand 

patterns of physical activity there,” Dr Moore explained. 

“We developed a questionnaire that emphasizes participation in everyday routine activities, such as light household work and activity as part of an occupation. We also 

included much greater representation of those exercise 

activities that are common among Shanghai residents.” 

The researchers validated this questionnaire against the 

objective accelerometer data and their initial analysis has 

been submitted for publication to a peer-reviewed medical 

journal. 

The scientists also collected blood and urine 

samples from the study subjects to determine the levels of 

several biomarkers related to chronic low-grade inflammation and also to cancer risk. The researchers will 

analyze whether different types and intensities of physical 

activity, measured objectively by the accelerometers, are 

associated with circulating levels of these inflammation 

markers. The researchers will also analyze the bio-samples for potential biomarkers of short-term and long-term 

PA levels. 

Project Number: Z01 CP010197 

44 N C I C A M A N N U A L R E P O R T 2 0 0 8 
Understanding the Causes and Mechanisms of Cancer 

Treating Metabolic Syndrome is 

Studied to Reduce Pancreatic Cancer Risk

Division of Cancer Biology 

Two decades ago, the term “metabolic syndrome” was adopted by researchers and 

clinicians to describe the cluster of disease 

risk factors, including resistance to insulin, that develop as people accumulate 

excess weight. “Knowing these specific 

processes and targets in the body, we can 

begin to develop and evaluate ways to 

prevent and treat metabolic syndrome” as a 

way to reduce the risk of certain cancers (such 

as breast and prostate), as well as type 2 diabetes 

and cardiovascular disease, noted Jin-Rong Zhou, Ph.D., 

director of the Nutrition/Metabolism Laboratory at Beth 

Israel Deaconess Medical Center in Boston and assistant 

professor of surgery at Harvard Medical School. 

In 2007, Dr. Zhou was the co-director of a Harvard symposium on “Metabolic Syndrome and the Onset 

of Cancer,” where Dr. Zhou described NCI-supported 

work in his lab showing that a combination of dietary soy 

and green tea dramatically reduced four of the risk factors 

for metabolic syndrome in mice. 

So far, Dr. Zhou and others have provided 

evidence for this link only in breast and prostate cancer. 

He is now trying to determine whether the syndrome also 

increases the risk of pancreatic cancer. “We don’t really 

know what causes pancreatic cancer and have not been 

able to develop effective treatments,” he said. Pancreatic 

cancer is now the fourth leading cause of cancer death, 

which is why Dr. Zhou believes that finding preventive 

approaches is crucial. 

“We are seeing increases in both metabolic 

syndrome and pancreatic cancer in the population,” Dr. 

Zhou explained. “If one is causing the other, and we can 

treat the development of metabolic syndrome, it could 

prevent a lot of disease that we really don’t know how to 

otherwise effectively treat.” 

With funding from NCI*, Zhou’s lab is exploring 

whether green and black tea can prevent metabolic syndrome in mice that are genetically-engineered to develop 

pancreatic cancer. By feeding the mice a 

diet high in fat and white sugars, the 

researchers can track elements of the 

metabolic syndrome to see which may 

be contributing directly to the appearance and growth of the cancer. “The 

pancreas is the major organ producing 

insulin,” Dr. Zhou noted. “We think 

that one of the core risk factors for metabolic syndrome – insulin resistance – could 

be a factor in pancreatic cancer development.” 

In his earlier work using a mouse model with 

prostate cancer, Zhou found that mice given compounds 

extracted from both teas had significantly lowered body 

weight when compared to mice not given the tea extracts, 

although the groups consumed the same number of calories. Other biomarkers for metabolic syndrome were also 

reduced. The new study in pancreatic cancer mice will allow the researchers to evaluate how the diet might impact 

some of the other risk factors that comprise metabolic 

syndrome, including hypertension, low HDL cholesterol, 

and high triglycerides in the blood. Dr. Zhou’s research 

team will try to correlate changes in these risk factors 

with the development of pre-cancerous, pancreatic lesions 

in the mice. 

Many people drink green and black tea with 

minimum side effects, Dr. Zhou commented. Positive results from the mouse studies could lead directly to clinical 

trials in people, testing a preventive strategy for pancreatic cancer that is practical and safe. 

NCI Program Director Ming Lei, Ph.D., commented, “Dr. Zhou’s pilot study represents an increasingly 

important component of DCB’s cancer cell metabolism 

portfolio. Using well-controlled animal models, the 

research will provide high-quality experimental evidence 

that is critical for assessing the role of metabolic disorders 

in pancreatic cancer development, and the efficiency of 

natural products such as green tea as cancer prevention 

remedies.” 

*Grant Number: 1R21CA127794-02 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 45 
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.
�
Accelerating Progress in Cancer Prevention 

Kava Root Compound Shows Promise 

for the Prevention of Bladder Cancer 

Division of Cancer Prevention 

Exposure to carcinogens from both tobacco 

and those associated with working in some 

industries are known risk factors for bladder cancer. Bladder cancer researchers are 

interested in certain chemicals in foods or 

dietary supplements that may help protect 

against tumor formation and those that 

naturally concentrate in the urine and pass 

through the bladder. 

Xiaolin Zi, Ph.D., associate professor 

of urology at the University of California, Irvine, 

is examining a compound found in kava root called 

flavokawain A as a potential bladder cancer preventative. 

“In the western Pacific islands, where people 

drink kava beverages like we drink wine, incidences of 

bladder cancer are low despite high smoking rates,” 

Dr. Zi noted. “I’ve been investigating whether kava extracts, specific chemical components in kava extracts, or 

combinations of kava chemicals have anti-bladder cancer 

activity, and if so, how specific kava compounds can be 

used for preventing bladder cancers in smokers or even 

for reducing the risk of bladder cancer recurrence.” 

In earlier studies,* Dr. Zi and his colleagues 

performed extensive laboratory analyses of the chemical components of kava root extract, including several 

belonging to a chemical family called the chalcones. 

The chalcone flavokawain A had the strongest antiproliferative effect (reducing cell division) and apoptotic effect 

(causing cell death) in human bladder cancer cell lines 

derived from several different stages of the disease. 

Further studies** showed that the effects of 

flavokawain A are dependent on a gene called p53, a 

known tumor-suppressor gene that is mutated in many 

tumor types. Bladder cancer cells with defective p53 

were actually more sensitive to growth inhibition by 

flavokawain A. The kava compound appears to induce 

apoptosis by re-activating several genes normally controlled by p53 through a complex cell-signaling pathway, 

Dr. Zi explained. 

Flavokawain A also reduced tumor growth by 

64 percent in mice implanted with bladder cancer cells in 

these studies. With NCI funding,*** Dr. Zi is currently 

exploring flavokawain A’s anti-cancer effects in several more 

complex mouse models of bladder cancer, 

in a series of experiments expected to 

conclude in 2012. 

In one of these models, mice are 

exposed to the carcinogen 4-hydroxybutyl (butyl) nitrosamine (OH-BBN), 

which causes tumors that mimic 

bladder cancer development in smokers. “This model will be used to test the 

usefulness of flavokawain A for preventing 

the occurrence of bladder cancer in heavy 

smokers,” explained Dr. Zi. 

Two additional transgenic mouse models of 

bladder cancer will also be used. “These models recapitulate two different molecular pathways leading to two 

different types of bladder cancer,” said Dr. Zi. “We’ll use 

these models to test if flavokawain A can decrease the 

recurrence of bladder cancer or prevent the progression 

of bladder cancer into invasive disease, what’s sometimes 

called secondary prevention.” 

Dr. Zi noted, “Available treatments for preventing bladder cancer recurrences are associated with 

significant toxicities. We hope that flavokawain A or its 

derivatives will be a non- or less-toxic oral agent for preventing bladder cancer recurrence, and also for bladder 

cancer prevention in heavy smokers and people working 

in a number of high-risk industries.” 

NCI Program Director for the study Vernon 

Steele, Ph.D., M.P.H., commented, “Preventing bladder cancer recurrence and bladder cancer prevention are 

important goals in the field of cancer prevention. This 

is especially true in heavy smokers and people working 

in high-risk occupations. Hopefully, flavokawain A or 

its analogues will be non- or less-toxic oral agents for 

preventing bladder cancer recurrence and prevention. 

Positive animal results in a cancer prevention model will 

help support further development of these agents.” 

*Zi X, Simoneau AR. Flavokawain A, a novel chalcone from kava 

extract, induces apoptosis in bladder cancer cells by involvement of Bax 

protein-dependent and mitochondria-dependent apoptotic pathway and 

suppresses tumor growth in mice. Cancer Research, April 15, 2005; 

65(8):3479-86. 

**See page 66 for the reference. 

***Grant Number: 1R01CA122558-2 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 47 
Accelerating Progress in Cancer Prevention 

Dietary Compounds that Affect the 

Epigenome Tested for Cancer Prevention

Division of Cancer Prevention 

The list of known genetic mutations that can lead to 

cancer grows daily. In addition, scientists have discovered 

another layer of complexity driving abnormal gene expression in the disease: epigenetics. Epigenetic changes are 

changes to a chromosome’s structure that do not change 

the genetic sequence itself, but nonetheless change the 

way genes are expressed within cells. 

For example, a type of epigenetic change – called 

histone acetylation – controls whether or not a gene 

can be transcribed into RNA. If too many acetyl groups 

are removed by enzymes called histone deacetylases 

(HDACs), the DNA becomes wound too tight and cannot physically be reached by a cell’s transcription factors 

(proteins that control the translation of DNA into RNA). 

If this complex sequence of events results in “silencing” 

a tumor suppressor gene, the result can be a cancer cell. 

A group of compounds called HDAC inhibitors, 

which stop the removal of acetyl groups, have shown 

promise for the treatment of several cancer types. Roderick Dashwood, Ph.D., director of the Cancer Chemoprotection Program at the Linus Pauling Institute at Oregon 

State University, is exploring the use of HDAC inhibitor 

compounds found in foods as potential chemopreventive 

agents for colorectal cancer. 

His work so far has concentrated primarily on 

sulforaphane, a compound found in cruciferous vegetables such as broccoli. Researchers had previously focused 

on sulforaphane as an inducer of cells’ natural detoxification enzymes, which can add polar groups to carcinogens 

and help remove them from the cells. 

“In some studies, carcinogens were given to 

animals and then followed later by doses of sulforaphane. 

Tumor suppressor effects were still noted,” Dr. Dashwood 

explained. “If the entire protection was related to induction of detoxification enzymes and enhanced carcinogen 

excretion, that wouldn’t explain why, in an animal that has 

already been exposed to a colon carcinogen, sulforaphane 

would still be effective.” He added, “When we treated 

colon cancer cells with sulforaphane, we saw certain genes 

being turned on in a way that resembled the effects of some 

HDAC inhibitor drugs, such as vorinostat,” which is approved for the treatment of cutaneous T-cell lymphoma. 

In a previous study*, Dr. Dashwood and his 

colleagues first showed that metabolites of sulforaphane 

act as HDAC inhibitors and can re-activate a gene called 

p21, which arrests the cell cycle. They also showed that 

sulforaphane in the diet suppressed colon tumor formation in a mouse model and that the compound both increased acetylation of the histones and expression of p21. 

In a human pilot study, a single large serving of 

broccoli sprouts – a food naturally high in glucoraphanin, 

the precursor of sulforaphane – was enough to cause significant HDAC inhibition as measured in the participants’ 

peripheral blood mononuclear cells, within 3 hours after 

eating the broccoli sprouts. 

With NCI funding **, Dr. Dashwood’s research 

team is currently expanding their studies of sulforaphane 

and other potential dietary HDAC inhibitors. In cell cultures, Dashwood’s team is investigating which individual 

HDACs (HDAC1, HDAC2, etc.) control the expression 

of p21 and which are affected either by sulforaphane or 

organosulfur compounds from garlic, including the metabolite allyl mercaptan. 

However, a detailed understanding of the 

molecular pathways affected by dietary HDAC inhibitors is needed before moving to clinical trials, Dr. Dashwood cautioned. “We still don’t really know precisely 

what group of genes and downstream pathways specific 

HDACs are regulating in colon cancer cells versus prostate cancer cells.” By studying weaker dietary HDAC 

inhibitors, “we hope to provide new insights into ways to 

avoid serious side effects while maintaining therapeutic 

efficacy,” he added. 

NCI Program Director Sharon Ross, Ph.D., 

M.P.H., commented, “NCI’s Division of Cancer Prevention believes this project is significant because it will enhance our understanding of how dietary factors in broccoli and garlic, working through epigenetic mechanisms, 

may increase the expression of tumor suppressor genes, 

thereby halting aberrant proliferation and/or inducing 

death of abnormal cells. These studies should inform 

future dietary intervention trials for cancer prevention.” 

*Myzak MC, Karplus PA, Chung FL, Dashwood RH. A novel mechanism of chemoprotection by sulforaphane: inhibition of histone deacetylase. Cancer Research, August 15, 2004; 64(16):5767-74. 

**Grant Number: 1R01CA122959-1 

48 N C I C A M A N N U A L R E P O R T 2 0 0 8 

Accelerating Progress in Cancer Prevention 

Dietary Flavonols Tested for 

Colorectal Cancer Prevention

Center for Cancer Research 

The NCI Polyp Prevention Trial (PPT) was a multicenter, 

randomized clinical trial, with almost 2,000 individuals, 

that tested whether a diet (high-fiber, low-fat, and high in 

fruits and vegetables) could prevent the recurrence of precancerous adenomas (polyps) in the colon and rectum. 

However, the researchers found no preventive effect of 

the healthy diet on polyp recurrence, even after long-term 

follow up. 

Gerd Bobe, Ph.D., a research fellow in NCI’s 

Laboratory of Cancer Prevention, decided to take a closer 

look at the data from the PPT, focusing on the study 

participants’ intake of flavonols. Flavonols are bioactive 

compounds in plant-derived foods found in high concentrations in beans, onions, apples, and tea. 

“Two recent case-control studies* had shown 

a protective effect of flavonols against colorectal cancer, 

and another analysis, specifically of fruit and vegetable intake of the PPT participants, had shown that food groups 

rich in flavonols were more protective,” said Dr. Bobe. 

He and his NCI colleagues discovered that a 

high intake of flavonols by some PPT participants was 

associated with a significantly decreased risk of advanced 

adenoma recurrence compared with study participants 

who had a very low intake of the compounds. 

At NCI**, Dr. Bobe is currently testing several 

individual flavonol compounds for colorectal cancer 

prevention in a two-stage mouse model of carcinogenesis. 

The mice are first exposed to a known carcinogen, azoxymethane, and then a colon irritant, dextran sodium sulfate, to specifically initiate tumors in the gastrointestinal 

tract. Then, they are given different flavonol compounds 

to test the effects. 

These experiments will go beyond identifying 

the most effective flavonols and the best dosage levels for 

preventing the formation of colorectal tumors in the mice. 

Dr. Bobe and his colleagues also hope to identify the 

molecular targets for the most promising flavonols. The 

researcher team will also attempt to determine if there 

are any reliable biomarkers in the blood that can indicate 

whether a flavonol compound is hitting the molecular 

target and suppressing tumor formation in the mice. 

Dr. Bobe and his colleagues have already demonstrated in previous studies*** the effectiveness of 

navy beans as colon cancer preventives. They were able 

to show that cooked navy beans and their residue or 

extracts reduced the formation of colon lesions in obese 

mice exposed to azoxymethane. They found that the navy 

bean diet altered a panel of genes associated with inflammation and identified two proteins that could potentially 

serve as biomarkers of the diet’s anti-carcinogenic effect. 

After performing similar experiments with 

flavonols in their two-step mouse model of colorectal 

tumor formation, “we’re going to go back to analyze the 

data from the PPT,” explained Dr. Bobe. “We have serum 

samples stored from the trial and detailed dietary data, 

and we’ll look to see whether we can relate the dietary 

data to levels of the serum biomarkers we identify in our 

animal studies.” 

He and Nancy Colburn, Ph.D., director of the 

NCI Laboratory of Cancer Prevention, hope to eventually 

conduct a short-term feeding study in about 30 or 40 human volunteers, who would receive a flavonol supplement 

for four weeks and would be monitored for inflammation 

by changes in biomarkers. This planned experiment will 

depend upon preclinical data that validates biomarkers 

for flavonols’ ability to hit their putative molecular targets 

successfully. 

* Bobe G, Sansbury LB, Albert PS, Cross AJ, Kahle L, Ashby J, Slattery ML, Caan B, Paskett E, Iber F, Kikendall JW, Lance P, Daston C, 

Marshall JR, Schatzkin A, Lanza E. Dietary flavonoids and colorectal 

adenoma recurrence in the Polyp Prevention Trial. Cancer Epidemiology, Biomarkers & Prevention, June 2008; 17(6):1344-53. 

*** Mentor-Marcel RA, Bobe G, Barrett KG, Young MR, Albert PS, 

Bennink MR, Lanza E, Colburn NH. Inflammation-associated serum 

and colon markers as indicators of dietary attenuation of colon carcinogenesis in ob/ob mice. Cancer Prevention Research, January 2009; 

2(1):60-9. 

**Project Number: Z01BC010025 

50 N C I C A M A N N U A L R E P O R T 2 0 0 8 

Accelerating Progress in Cancer Prevention 

Environmental and Nutritional Links to 

Esophageal Cancer Found Globally

Division of Cancer Epidemiology and Genetics 

Christian Abnet, Ph.D., M.P.H., has literally traveled around the world in search of 

answers to questions about what causes 

esophageal and gastric (stomach) cancers. 

The investigator from NCI’s Nutritional 

Epidemiology Branch has focused his research sleuthing on high-risk populations 

for these diseases in China, Iran, Ireland, 

South America, and Africa. 

The populations in those regions 

have little in common ethnically, culturally, or 

genetically, so Dr. Abnet tries to identify any “unifying theme” that might tie their high rates of cancer to 

shared risk factors. For example, people living in certain areas of China, Iran, and Brazil have moderate to 

very high rates of esophageal squamous cell carcinoma 

(ESCC). The connecting thread among these far-flung 

pockets of the disease may be high levels of human exposure to a group of compounds called polycyclic aromatic 

hydrocarbons (PAH), including the known carcinogen 

benzo[a]pyrene. 

“In Linxian, China, the PAH exposures are from 

both cooking and heating,” Dr. Abnet explained. “They 

use coal and unventilated stoves, so they’re exposed 

directly to PAHs from breathing the coal smoke. They’re 

exposed indirectly from smoke deposits on their food.” 

He and his colleagues are still trying to determine 

the source of high exposure to PAHs in northern Iran. 

However, in their studies in Brazil, where there are moderately high rates of ESCC, PAH exposure was surprisingly linked to drinking the popular regional beverage, 

maté– an herbal tea. “We’ve done some work to show 

that the amount of benzo[a]pyrene and other PAHs in 

maté is actually quite high,” Dr. Abnet said. With maté 

drinkers typically consuming one or more liters a day, 

their exposure levels can be substantial. 

Dr. Abnet’s research is intended to have 

public health impact through prevention 

programs in areas of the world where 

resources for treating cancer and other 

serious diseases are limited. 

“In China, there is the possibility for change in the way people 

cook and heat their homes, such as adding chimneys for their stoves,” he noted. 

In South America, “we found variations in 

the amount of PAHs in the different brands of 

maté,” Dr. Abnet recalled. “So it seems possible to 

find ways to process the plant leaves in a way that would 

lower PAH exposure in drinkers, or people may want to 

avoid drinking maté.” 

Based on his and his colleagues’ earlier research 

in China, “We have clinical trial and observational epidemiological studies suggesting that the lack of selenium in 

the diet is a critical determinant of the high risk for ESCC 

in certain regions. Selenizing salt may be beneficial,” Dr. 

Abnet believes. “We’ve been discussing with our Chinese 

research colleagues whether or not it’s time for at least a 

demonstration project where they would selenize salt and 

look at how it affects the population’s levels of selenium 

and the subsequent cancer rates.” 

To conduct this wide-ranging research, Dr. Abnet 

and his collaborators have “built population resources in 

different parts of the world where we’ve collected, either 

through case-control or cohort studies, large datasets and 

biospecimens for studying cancers in high-risk populations,” he said. “We have quite a few ongoing studies 

looking at several nutrients in addition to selenium. For 

example, in our study in China, we’re in the middle of a 

project to look at serum vitamin C status in relation to 

the risk of both ESCC and gastric cancer.” 

Project Numbers: Z01-CP000185 and Z01-CP000112 

52 N C I C A M A N N U A L R E P O R T 2 0 0 8 
Accelerating Progress in Cancer Prevention 

Green Tea Shows Promise in 

Preventing Pancreatic Cancer

Office of Cancer Complementary and Alternative Medicine
�

Division of Cancer Treatment and Diagnosis
�

Pancreatic cancer is highly resistant to current 

chemotherapy and radiotherapy treatments, 

and therefore, it presents one of the most 

difficult challenges for cancer clinicians 

and patients. These challenges provide 

researchers a strong mandate to develop 

better treatments than currently exist. 

“We really need new [treatment] 

options,” said Rakesh Srivastava, Ph.D., at 

the University of Texas Health Science Center 

at Tyler. Pancreatic cancer is difficult to detect 

in its early stages, he explained. However, when researchers study the disease’s progression in the laboratory 

and in precancerous lesions, pancreatic intraepithelial 

neoplasias (PanINs), these conditions are usually much 

more treatable than the usually lethal cancer that will 

present itself clinically in later stages. 

With funding from NCI*, Dr. Srivastava’s 

biochemistry lab is pursuing a lead that has powerful 

implications from epidemiological studies in China and 

Japan. A great deal of green tea is consumed daily in 

those regions, which also have the lowest rates of prostate 

and stomach cancer in the world. These populations may 

be benefiting from epigallocatechin-3-gallate (EGCG), a 

polyphenolic ingredient in green tea that previous laboratory research shows to be an effective anti-cancer component in that beverage. 

Dr. Srivastava is trying to chart the mechanisms 

involved in green tea’s preventive effect, as well as trying 

to determine whether EGCG also works against PanINs. 

He and his colleagues will develop an oral dose of EGCG 

for mice and track the molecular impact of 

the compound on the animals’ early signs 

of pancreatic cancer. 

One of the earliest genetic steps 

on the path to development of PanINs 

is mutations in the K-ras gene, “which 

we see highly expressed in more than 

90 percent of invasive carcinomas,” 

Dr. Srivastava explained. Based on 

work from previous studies, the researchers are demonstrating how EGCG inhibits 

this particular altered metabolic pathway. 

“EGCG’s effect on pancreatic cancer appears 

to be multi-pronged,” Dr. Srivastava added. Early-stage 

cancer cells proliferate by going through a series of cycles, 

but EGCG induces some specific inhibitors to interfere 

with this process. In addition, he has long been focused 

on the study of apoptosis, a form of programmed cell 

death, which cancer cells generally find ways to evade. He 

has found that EGCG blocks some of the cellular processes that inhibit apoptosis in cancer cells. 

“What is promising about EGCG is the redundancy of its protective effects,” said Dr. Srivastava. “As a 

potential non-toxic, dietary preventive, green tea seems to 

carry a whole program of anti-cancer tools.” 

OCCAM Program Director Dan Xi, Ph.D., commented, “This study is highly significant, because pancreatic adenocarcinoma still ranks as the most challenging of 

human malignancies, with an overall five-year survivorship of only three percent.” 

*Grant Number: 1R01CA125262-1 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 53 
Accelerating Progress in Cancer Prevention 

Ginger Extract to Be Tested for 

Lung Cancer Prevention

Office of Cancer Complementary and Alternative Medicine 

Division of Cancer Treatment and Diagnosis 

Lung cancer currently causes the greatest number of 

cancer-related deaths in the United States, and no drugs 

are available to help prevent the disease. Shengmin Sang, 

Ph.D., assistant professor in the Human Nutrition Research Program at the North Carolina Central University, 

is studying whether several compounds isolated from the 

herb ginger could potentially be used to prevent the development of lung cancer. 

“Ginger is currently one of the popular dietary 

supplements in the U.S. market, and it has recently started 

receiving attention from researchers due to its potential 

antioxidant, anti-inflammatory, and anti-cancer activity,” 

said Dr. Sang. 

In earlier laboratory studies*, Dr. Sang and his 

colleagues showed that a compound isolated from dried 

ginger, 6-shogaol, inhibited the growth of human cancer 

cells and induced apoptosis (cell death) in a colorectal 

cancer cell line by destroying the mitochondria, the organelles that produce cellular energy. 

Much of the previous work testing ginger as 

an anti-cancer agent has focused on compounds called 

gingerols, which are found in fresh ginger. Shogaols are 

formed when ginger is dehydrated. “In our studies, we 

have found that shogaols have much stronger anti-inflammatory and anti-carcinogenic activity than gingerols,” 

explained Dr. Sang. 

One of the challenges for research using botanicals and dietary supplements, explained Dr. Sang, is that 

there are many compounds with biological activity in any 

one product. The levels of these compounds can also vary 

from batch-to-batch in commercial products. When 

Dr. Sang tested several ginger preparations purchased 

from a supermarket, the levels of shogaols and gingerols 

varied substantially among different products. 

With funding from the NCI,** Dr. Sang’s laboratory is creating a standardized ginger extract high in 

shogaols. They plan to quantify the levels of shogaols and 

gingerols in the extract, identify any other bioactive compounds in the final product, and determine the bioavailability of any compounds with anti-cancer activity. 

Once they have developed a standardized ginger 

extract, they will test it in a mouse model of lung carcinogenesis. In this model, mice will be exposed to a lung 

carcinogen called 4-(Methylnitrosamino-1-(3-pyridyl)­

1-butanone (called NNK), which is found in tobacco. 

Different groups of mice will receive either the standardized ginger extract or extract from fresh ginger before, or 

after, carcinogen exposure. A third group of mice will not 

receive ginger. Tumor development will be compared between mice that did or did not receive the ginger extracts. 

“The development of a standardized and moreactive ginger extract preparation will facilitate future 

pre-clinical and clinical studies on the health benefits of 

ginger,” said Dr. Sang. “If a standardized ginger extract 

can be developed into a lung cancer preventive agent, the 

public health benefit would be tremendous.” 

* Pan MH, Hsieh MC, Kuo JM, Lai CS, Wu H, Sang S, Ho CT. 

6-Shogaol induces apoptosis in human colorectal carcinoma cells via 

ROS production, caspase activation, and GADD 153 expression. Mol 

Nutr Food Res, 2008 May; 52(5):527-37. 

**Grant Number: 1R21CA138277-01A2 

54 N C I C A M A N N U A L R E P O R T 2 0 0 8 

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. 
Developing Effective and Efficient Treatments 

Plant Compounds Show Effects 

Against Prostate Cancer Stem Cells

Center for Cancer Research 

Scientists at NCI’s CCR are finding early 

evidence that some plant-based compounds 

(phytochemicals) – specifically parthenolide, from the Chinese herbal medicine 

feverfew and gossypol, a compound isolated from cotton-seed oil – can inhibit or 

eliminate cancer stem cells (CSCs). CSCs 

are increasingly viewed as the driving force 

behind relapse and chemotherapy resistance 

in prostate and other cancers. 

A growing body of evidence has identified 

CSCs, also called tumor-initiating cells, as the major cause 

of tumor progression, explained William Farrar, Ph.D., 

head of CCR’s Cancer Stem Cell Section and an investigator for the phytochemical study on prostate cancer which 

is supported by OCCAM.* 

Cancer stem cells are believed to be a small 

subpopulation of cells within a tumor that are able to 

self-renew as well as give rise to more differentiated tumor cells. It is thought that these stem cells survive initial 

therapies (such as chemotherapy and hormone therapy) 

and then generate new tumor cells that are resistant to 

standard treatments. If prostate cancer stem cells could be 

identified and characterized, it might be possible to design 

treatments that prevent resistance. 

CSCs are distinct from the cancer “progeny 

cells,” which are created by CSCs and make up the bulk 

of most tumors. Current cancer treatments focus on destroying the progeny cells “but in many cases, even after 

the tumor is reduced or seemingly eliminated, it grows 

back and becomes resistant to further 

treatment,” Dr. Farrar added. Many 

researchers now believe that the CSCs 

often survive initial treatment and 

act like “evil seeds” that regrow new, 

more treatment-resistant progeny 

cells. 

In the study of parthenolide,** 

the researchers found that the compound 

killed more than 90% of CSCs in several 

prostate cancer cell lines and in primary 

prostate cancer cells. These findings were validated in 

mice that were grafted (xenografts) with prostate CSCs 

and treated with parthenolide. Previous research showed 

the compound was also effective against CSCs for certain 

leukemias, which may be the focus of the first human 

clinical trial of parthenolide, Dr. Farrar noted. 

In future studies, Dr. Farrar’s lab will expand 

its library of phytochemicals, including curcumin and 

quercetin, and isolate CSCs to determine the effectiveness of plant compounds for other cancers. “Besides just 

killing CSCs, we want to look at whether we can block 

their ability to metastasize,” he said. “We want to get 

particularly aggressive with researching CSCs’ impact on 

pancreatic cancers.” 

**Kawasaki BT, Hurt EM, Kalathur M, Duhagon MA, Milner Ja, 

Kim YS, Farrar WL. Effects of the sesquiterpene lactone parthenolide on 

prostate tumor-initiating cells: An integrated molecular profiling 

approach. The Prostate, June 1, 2009; 69(8): 827-37.
�

*Project Number: Z01BC010794 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 57 
Developing Effective and Efficient Treatments 

Traditional Chinese Medicine Treatment 

May Enhance Chemotherapy

Center for Cancer Research 

An herbal mixture used in traditional Chinese 

medicine for over 1,700 years for gastrointestinal problems including diarrhea, 

nausea, and vomiting has been reformulated in the U.S. This reformulation 

–PHY 906 – interested U.S. researchers looking for new and better ways 

to treat the often severe gastrointestinal side effects that can result from 

chemotherapy. 

Yung-Chi Cheng, Ph.D., Henry 

Bronson Professor of Pharmacology at 

the Yale University School of Medicine, first 

looked at the ability of PHY 906 to lessen the gastrointestinal side effects of chemotherapy nine years ago. In an 

early small clinical study, the compound was successful in 

reducing the side effects in colon cancer patients receiving 

the drugs irinotecan and 5-FU. 

In animal studies, Dr. Cheng and his colleagues 

observed a synergistic anti-cancer effect of the compound 

when given in combination with irinotecan. Although 

PHY 906 had no effect on animal tumors when given 

alone, irinotecan plus PHY 906 had greater anti-tumor 

activity than irinotecan alone. 

“Initially, we didn’t expect antitumor activity. 

We were testing PHY 906 purely for relieving side effects,” 

said Dr. Cheng. 

PHY 906 is being tested for potential anti-cancer 

activity in combination with chemotherapy drugs in three 

different clinical trials: irinotecan for advanced colon cancer resistant to first-line treatment; capecitabine in liver 

cancer; and capecitabine in pancreatic cancer resistant to 

first-line gemcitabine. In the pancreatic study, the hope 

is that reducing the side effects with PHY 906 will allow 

greater doses of the drug to be given. 

So far, preliminary results from all three studies 

have been promising. In the study with liver cancer patients, the combination appeared to provide a significant 

survival advantage (compared to historical controls) in 

Asian patients but not Caucasian patients, although the 

number of participants was too small to draw definitive 

conclusions. In the pancreatic cancer study, the addition of PHY 906 allowed for a 50% dose escalation of 

capecitabine without an increase in side-effects. 

One concern with any natural product preparation is consistency, as the levels of active compounds in herbs or other plants can vary from 

batch to batch and year to year. Dr. Cheng 

and his colleagues have been able to show 

that a consistent preparation of PHY 906 

can be achieved* by using the tools of 

mass spectrometry and RNA fingerprinting, which allow different herbal mixtures’ 

effects on RNA expression to be compared. 

“The next question was, how exactly 

does PHY 906 enhance the anti-cancer activity 

of chemotherapy drugs?” noted Dr. Cheng. In 2008, 

his laboratory collaborated with Francesco Marincola, 

M.D., chief of the Infectious Disease and Immunogenetics Section at the NIH Clinical Center**. Dr. Marincola’s 

laboratory has extensive experience using RNA technology 

to look at the tumor microenvironment under different 

treatment conditions. 

Dr. Marincola is now using whole mouse genome 

arrays to look at global RNA expression after PHY 906 

and chemotherapy drug administration. “We were initially looking for immune altering effects of PHY 906,” he 

explained. “That was our hypothesis of how it worked.” 

His lab analyzed tumor samples, comparing 

untreated animals with those treated with chemotherapy 

only, PHY 906 alone, or the combination. The analysis 

demonstrated that the herbal formula, when used alone, 

has potent anti-inflammatory activity that lessens the 

chronic inflammatory process caused by cancer cells. 

The combination of PHY 906 and chemotherapy causes 

a potent inflammatory response similar to that observed 

during rejection of allografts or of cancer cells during 

immunotherapy, Dr. Marincola added. “These findings 

suggest that the PHY 906 may enhance the effects of chemotherapy by adding an anti-cancer immune response.” 

Future work will look at whether the combination 

of the herbs and chemotherapy impacts tissues other than 

those affected by cancer, and if so, what the effects might be. 

*Ye M, Liu SH, Jiang Z, Lee Y, Tilton R, Cheng YC. Liquid chromatography/mass spectrometry analysis of PHY906, a Chinese medicine 

formulation for cancer therapy. Rapid Communications in Mass Spectrometry, 2007; 21(22):3593-607. 

**Project Number: 5R01CA063477-13 

58 N C I C A M A N N U A L R E P O R T 2 0 0 8 
Developing Effective and Efficient Treatments 

Cruciferous Vegetables Studied for Prevention 

and Treatment of Pancreatic Cancer 

Office of Cancer Complementary and Alternative Medicine
�

Division of Cancer Treatment and Diagnosis
�

Pancreatic cancer is one of the most aggressive and lethal solid tumor diseases. Four in 

five patients live for less than a year after 

diagnosis and less than five percent reach 

the five-year benchmark often used to assess cancer survival rates. Researchers are 

pursuing various approaches to address 

the urgent need for new and targeted 

therapeutics for pancreatic cancer. 

Among the treatments that have 

shown early promise in pre-clinical studies is 3,3­ -diindolylmethane (DIM), a bioactive 

metabolic component of indole-3-carbinol (I3C) found 

in cruciferous vegetables like broccoli, Brussels sprouts, 

and cauliflower. Many cancer researchers studying this 

compound use a special formulation manufactured by 

BioResponse, Inc. called B-DIM. In several experiments, 

B-DIM has inhibited mTOR and Akt, two important 

molecular pathways in cell proliferation and invasion. 

Fazlul Sarkar, Ph.D., professor of pathology at 

Wayne State University School of Medicine, is experimenting in cell cultures and with mice to demonstrate 

how B-DIM might effectively prevent as well as treat pancreatic cancer. “With many tumors, there is a switch that 

seems to unleash the cancer process,” he explained. The 

culprit in pancreatic cancer may be a recently discovered 

member of the platelet-derived growth factor (PDGF) 

family known as PDGF-D. “We find it prominently expressed in many of the tumors,” Dr. Sarkar added. 

This NCI-supported research* is designed to 

study what happens to the development of pancreatic 

cancer cells when PDGF-D production is slowed (turned 

down) by B-DIM, focusing in particular on the impact on 

cancer stem-like cells. Cancer stem-like cells are the cells 

in pancreatic and other cancers that drive the reproduction and treatment resistance of cancer cells. 

The first prominent effect on pancreatic cells 

in culture is interference with the expression of a gene 

called Notch-1, which has a role in cell growth. When 

Notch-1 is activated, so too is another of the main factors 

driving tumor progression and metastasis, 

NF-­ B, which could be reduced by B-DIM, 

Dr. Sarkar noted. In turn, two of NF­

­ B’s downstream gene targets are also 

impaired by B-DIM: MMP-9, a matrix 

metallopeptidase, which also helps 

cells to spread in the body and aids in 

bringing a new blood supply (angiogenesis) to the developing pancreatic 

tumor; and vascular endothelial growth 

factor, which also spurs angiogenesis, as 

well as other major steps in the cancer process. 

All of these cancer-promoting factors are 

reduced when PDGF-D is turned down. “We’re confident 

of the results from B-DIM administration in cell culture,” 

said Dr. Sarkar, “because when we went the other way 

and turned up the PDGF-D production, all of these genes 

and carcinogenic effects increased.” 

The next step, now underway, is to confirm that 

the same set of cellular processes actually happens in mice 

that are genetically altered to develop and mimic human 

pancreatic cancer. If that animal disease model proves responsive, Dr. Sarkar and his colleagues will test B-DIM as 

a way to turn down the PDGF-D production in the mice. 

The final step in this research strategy would be human 

clinical trials to test whether B-DIM could actually work 

as a non-toxic, dietary chemopreventive agent. “It may 

also be used in conjunction with conventional therapeutics to improve survival of patients diagnosed with this 

devastating disease,” he said. 

NCI Program Director Isis Mikhail, M.D., 

M.P.H., Dr.P.H., commented, “I am very pleased with Dr. 

Sarkar’s progress on his innovative research project on 

B-DIM. The identification of novel therapeutics from this 

natural product fits well within OCCAM’s Research Development and Support Program portfolio. The findings 

have promising translational results for the prevention 

as well as treatment of pancreatic cancer, moving it from 

bench to bedside.” 

*Grant Number: 1R01CA131151-02 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 59 
Improving the Quality of Life for Cancer Patients, 

Survivors, and their Families
�

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

Traditional Chinese Mind-Body Practice May 

Relieve Cancer Stress and Improve Quality of Life

Division of Cancer Prevention 

Researchers at M.D. Anderson Cancer Center 

are studying the traditional Chinese mindbody practice of qigong (pronounced 

CHEE-gong) among rectal cancer patients receiving radiation treatments. The 

researchers are examining qigong as a way 

to address the considerable distress, impaired quality of life (QOL), and reduced 

physical function rectal cancer patients 

experience. 

Qigong is an ancient practice in which 

individuals learn to channel their qi (internal energy flow) 

to benefit their physical, emotional, mental, or spiritual 

health. It incorporates stress-reduction techniques including regulated breathing, visual imagery, meditation, and 

various gentle movements, explained Lorenzo Cohen, 

Ph.D., director of the Integrative Medicine Program at 

M.D. Anderson Cancer Center in Houston, Texas. 

The qigong technique will be combined with the 

Chinese slow movement meditation practice of Tai Chi 

Chuan (TCC). The reason for this addition is the mixed 

results of a previous study. “Some NCI-funded research 

that we conducted in China in women with breast cancer 

used a very similar qigong program,” noted Dr. Cohen. 

“Our initial analysis found the intervention useful for 

helping to decrease levels of depression.” However, 

“it really had no other beneficial effects for relieving any 

of the physical side effects of treatment.” 

“We proposed to NCI* that we add on a TCC 

component to the qigong program for the rectal cancer 

study to increase the physical aspects of the intervention,” 

in hopes of getting beneficial results on the physical side 

effects of the treatment, he added. 

The patients will be taught a shortened form of 

TCC which consists of eight “very simple movements 

that are all linked together in flowing fashion,” Dr. Cohen 

said. He will compare the qigong/TCC group to a second 

study arm of patients who will be doing 

“what we call light exercise.” The addition of the exercise group is 

important, he explained, because “at 

the end of the study, we should be 

able to know if is there something 

about just physical activity and the 

extra attention you get by participating 

in one of these interventions, or whether 

there is actually something a bit more 

unique about the qigong program that’s useful 

for improving QOL.” 

There will also be a third group of patients, 

acting as a control, who receive no intervention. Each of 

the three study arms will enroll 50 rectal cancer patients. 

Participants in the qigong and exercise groups will attend 

practice sessions three days a week throughout their 

six-week radiotherapy schedule. QOL measures will be 

assessed among all patients at the beginning of the study 

and again at one and three months after radiation treatment ends. 

If the study is positive, showing unique effects of 

qigong/TCC, the researchers will conduct future studies 

to determine “what it is about qigong that improves these 

outcomes relative to exercise alone,” Dr. Cohen said. 

There may be other, simpler techniques more familiar to 

Western society that could produce similar results. 

“However, if we find that the qigong is better than a 

generic light exercise and relaxation program, it starts to 

open up a better understanding of these concepts from 

ancient Chinese medicine,” he added. 

NCI Program Director Ann O’Mara, Ph.D., 

commented, “Focusing this intervention on rectal cancer 

patients is laudatory, since rectal cancer is very understudied, in part, because of its rarity. This is the only project in 

our portfolio examining ways to mitigate the morbidities 

associated with rectal cancer and associated treatment.” 

*Grant Number: 5R21CA129201-02 

H I G H L I G H T S F R O M N C I ’ S W I D E - R A N G I N G C A M R E S E A R C H 61 
Improving the Quality of Life for Cancer Patients, Survivors, and their Families 

Breathing Exercises Studied to Ease 

Hot Flashes in Breast Cancer

Division of Cancer Control and Population Sciences 

Hot flashes associated with treatment-induced menopause 

in breast cancer survivors can cause stress, sleep disturbances, and otherwise negatively affect the quality of life 

for many women. The current medications and hormone 

therapies used to alleviate this bothersome condition are 

often not particularly effective or may not be a medical 

option for some survivors. This has led to an increase in 

research for nonpharmacological interventions for hot 

flashes. 

Slow, deep breathing has previously been recommended as a first-line treatment for hot flashes by 

the North American Menopause Society. However, the 

recommendation was based on two, small clinical studies 

in healthy women. “We thought we should repeat the 

studies on a larger scale, looking at a similar intervention 

in the breast cancer survivor community rather than just 

in menopausal women,” noted Janet S. Carpenter, Ph.D., 

R.N., professor of adult health at Indiana University 

School of Nursing. 

Under a grant from NCI*, Dr. Carpenter is conducting a randomized, controlled clinical study to evaluate a simple CD-ROM/DVD-based at-home training and 

practice program for a breathing intervention to relieve 

hot flashes. The study is enrolling 91 breast cancer survivors and 91 healthy women who are randomly assigned 

to one of the three study arms: 1) breathing program 1 

(40% of enrollees); 2) breathing program 2 (40%); or 3) 

a non-treatment group (20%). 

The previous clinical studies showed that if women practiced the technique for 15 minutes, twice-a-day 

and also applied the technique at the time of a hot flash, 

the frequency and severity of hot flashes decreased. “This 

effect may be due to the technique’s impact on balancing 

the parasympathetic and sympathetic nervous systems. 

We may apply for a supplement to our grant in order to 

determine how the intervention might be working,” 

Dr. Carpenter said 

All of the women in the study are assessed when 

they enroll in the study and at 8- and 16 weeks after the 

intervention ended. For a subset of women, a portable 

respiratory monitor will help evaluate if they are correctly 

applying the breathing technique. The women will also 

wear a small device that will serve as an electronic “diary” 

in which they will record the frequency and severity of 

hot flashes they have during the study period. 

“My early research shows that hot flashes result 

in negative mood, interference with daily life, and sleep 

disturbances,” Dr. Carpenter noted. “So we’re also 

measuring all of those outcomes in this study. What we’re 

hoping to do is get to a point where we’ve tested a series 

of interventions, so we can actually direct women to the 

best interventions for their cluster of symptoms.” 

*Grant Number: 5R01CA132927-02 

62 N C I C A M A N N U A L R E P O R T 2 0 0 8 

Scientific Publications 

This is a selected list of some of the most important peer-reviewed scientific articles about the findings and analyses of NCI-supported CAM research studies 

published during FY 2008. The articles are classified and grouped according 

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

symptom management. 

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

Medicine’s “PubMed” database at http://www.pubmed.gov. A PubMed Identifier (PMID) number is provided for each of the citations. 

Prevention 

Cho KN, Sukhthankar M, Lee SH, Yoon JH, 

Baek SJ. Green tea catechin (-)-epicatechin gallate induces tumour suppressor protein ATF3 via 

EGR-1 activation. European Journal of Cancer, 

November 2007; 43(16):2404-12. Epub Aug. 30, 

2007. PMID: 17764926. 

Deeb D, Gao X, Dulchavsky SA, Gautam SC. 

CDDO-Me inhibits proliferation, induces apoptosis, down-regulates Akt, mTOR, NF-kappaB 

and NF-kappaB-regulated antiapoptotic and proangiogenic proteins in TRAMP prostate cancer 

cells. Journal of Experimental Therapeutics and 

Oncology, 2008; 7(1):31-9. PMID: 18472640. 

Guo Y, Xie J, Rubin E, Tang YX, Lin F, Zi X, 

Hoang BH. Frzb, a secreted Wnt antagonist, decreases growth and invasiveness of fibrosarcoma 

cells associated with inhibition of Met signaling. 

Cancer Research, May 2008; 68(9):3350-60. 

PMID: 18451162. 

Katiyar SK. Grape seed proanthocyanidines and 

skin cancer prevention: inhibition of oxidative 

stress and protection of immune system. Molecular Nutrition and Food Research, June 2008; 52 

Suppl 1:S71-76. PMID: 18384090. 

Kim MH. Protein phosphatase 1 activation and 

alternative splicing of Bcl-X and Mcl-1 by EGCG 

+ ibuprofen. Journal of Cellular Biochemistry, 

July 2008; 104(4):1491-99. PMID: 18348186. 

Kim MH, Chung J. Synergistic cell death by 

EGCG and ibuprofen in DU-145 prostate cancer 

cell line. Anticancer Research, November-December 

2007; 27(6B):3947-56. PMID: 18225555. 

Lee JC, Bhora F, Sun J, Cheng G, Arguiri E, Solomides CC, Chatterjee S, Christofidou-Solomidou 

M. Dietary flaxseed enhances antioxidant defenses and is protective in a mouse model of lung 

ischemia-reperfusion injury. American Journal of 

Physiology-Lung Cellular and Molecular Physiology, February 2008; 294(2):L255-65. Epub 

Dec. 14, 2007. PMID: 18083772. 

Lee SH, Cekanova M, Baek SJ. Multiple mechanisms are involved in 6-gingerol-induced cell 

growth arrest and apoptosis in human colorectal 

cancer cells. Molecular Carcinogenesis, March 

2008; 47(3):197-208. PMID: 18058799. 

Mallery SR, Zwick JC, Pei P, Tong M, Larsen 

PE, Shumway BS, Lu B, Fields HW, Mumper RJ, 

Stoner GD. Topical application of a bioadhesive 

black raspberry gel modulates gene expression 

and reduces cyclooxygenase 2 protein in human 

premalignant oral lesions. Cancer Research, 

June 2008; 68(12):4945-57. PMID: 18559542. 

Meeran SM, Katiyar SK. Proanthocyanidins 

inhibit mitogenic and survival-signaling in 

vitro and tumor growth in vivo. Frontiers in 

Bioscience, January 2008; 13:887-97. PMID: 

17981597. 

64 N C I C A M A N N U A L R E P O R T 2 0 0 8 
Piyanuch R, Sukhthankar M, Wandee G, Baek 

SJ. Berberine, a natural isoquinoline alkaloid, 

induces NAG-1 and ATF3 expression in human 

colorectal cancer cells. Cancer Letters, December 2007; 258(2):230-40. Epub Oct. 25, 2007. 

PMID: 17964072. 

Sukhthankar M, Yamaguchi K, Lee SH, McEntee MF, Eling TE, Hara Y, Baek SJ. A green 

tea component suppresses posttranslational 

expression of basic fibroblast growth factor in 

colorectal cancer. Gastroenterology, June 2008; 

134(7):1972-80. Epub March 8, 2008. PMID: 

18549879. 

Shumway BS, Kresty LA, Larsen PE, Zwick JC, 

Lu B, Fields HW, Mumper RJ, Stoner GD, Mallery SR. Effects of a topically applied bioadhesive 

berry gel on loss of heterozygosity indices in premalignant oral lesions. Clinical Cancer Research, 

April 2008; 14(8):2421-30. PMID: 18413833. 

Treatment 

Billam M, Mukhi S, Tang L, Gao W, Wang JS. 

Toxic response indicators of microcystin-LR 

in F344 rats following a single-dose treatment. 

Toxicon, May 2008; 51(6):1068-80. Epub Feb, 

6, 2008. PMID: 18339415. 

Coleman MC, Asbury CR, Daniels D, Du J, 

Aykin-Burns N, Smith BJ, Li L, Spitz 

DR, Cullen JJ. 2-deoxy-D-glucose causes cytotoxicity, oxidative stress, and radiosensitization 

in pancreatic cancer. Free Radical Biology and 

Medicine, February 2008 ; 44(3):322-31. Epub 

Oct. 16, 2007. PMID: 18215740. 

Funahashi H, Satake M, Hasan S, Sawai H, 

Newman RA, Reber HA, Hines OJ, Eibl G. 

Opposing effects of n-6 and n-3 polyunsaturated 

fatty acids on pancreatic cancer growth. Pancreas, 

May 2008; 36(4):353-62. PMID: 18437081. 

Ghosh R, Garcia GE, Crosby K, Inoue H, 

Thompson IM, Troyer DA, Kumar AP. Regulation of Cox-2 by cyclic AMP response element 

binding protein in prostate cancer: potential 

role for nexrutine. Neoplasia, November 2007; 

9(11):893-9. PMID: 18030357. 

Lu M, Xia L, Hua H, Jing Y. Acetyl-keto-betaboswellic acid induces apoptosis through a 

death receptor 5-mediated pathway in prostate 

cancer cells. Cancer Research, February 2008; 

68(4):1180-86. PMID: 18281494. 

Lyon DE, McCain NL, Walter J, Schubert C. 

Cytokine comparisons between women with 

breast cancer and women with a negative breast 

biopsy. Nursing Research, January-February 

2008; 57(1):51-58. PMID: 18091292. 

Ma Y, Yu WD, Hershberger PA, Flynn G, Kong 

RX, Trump DL, Johnson CS. 1alpha, 25-Dihydroxyvitamin D3 potentiates cisplatin antitumor 

activity by p73 induction in a squamous cell 

carcinoma model. Molecular Cancer Therapeutics, September 2008; 7(9):3047-55. PMID: 

18790784. 

McAllister SD, Christian RT, Horowitz MP, 

Garcia A, Desprez PY. Cannabidiol as a novel 

inhibitor of Id-1 gene expression in aggressive 

breast cancer cells. Molecular Cancer Therapeutics, November 2007; 6(11):2921-7. PMID: 

18025276. 

Ostberg JR, Dayanc BE, Yuan M, Oflazoglu E, 

Repasky EA. Enhancement of natural killer (NK) 

cell cytotoxicity by fever-range thermal stress is 

dependent on NKG2D function and is associated 

with plasma membrane NKG2D clustering and 

increased expression of MICA on target cells. 

Journal of Leukocyte Biology, November 2007; 

82(5):1322-31. Epub Aug. 21, 2007. PMID: 

17711975. 

S C I E N T I F I C P U B L I C AT I O N S 65 
Wang X, Patet R, Studzinski GP. hKSR-2, a 

vitamin D-regulated gene, inhibits apoptosis in 

arabinocytosine-treated HL60 leukemia cells. 

Molecular Cancer Therapeutics, September 

2008; 7(9):2798-806. PMID: 18790760. 

Side Effect/Symptom Management 

Deng G, Vickers A, Yeung S, D’Andrea GM, 

Xiao H, Heerdt AS, Sugarman S, Troso-Sandoval 

T, Seidman AD, Hudis CA, Cassileth B. Randomized, controlled trial of acupuncture for the 

treatment of hot flashes in breast cancer patients. 

Journal of Clinical Oncology, December 2007; 

25(35):5584-90. Erratum in: Journal of Clinical 

Oncology, March 2008; 26(9):1572. D’Andrea 

GM [added]; Xiao H [added]; Heerdt AS [added]; Sugarman S [added]; Troso-Sandoval T 

[added]; Seidman AD [added]; Hudis CA 

[added]. PMID: 18065731.

Nelson EL, Wenzel LB, Osann K, Dogan-Ates 

A, Chantana N, Reina-Patton A, Laust AK, 

Nishimoto KP, Chicz-DeMet A, du Pont N, 

Monk BJ. Stress, immunity, and cervical cancer: 

biobehavioral outcomes of a randomized clinical trial [corrected]. Clinical Cancer Research, 

April 2008; 14(7):2111-8. Erratum in: Clinical 

Cancer Research, May 2008; 14(9):2892. PMID: 

18381952.

Zhang RX, Li A, Liu B, Wang L, Ren K, Zhang 

H, Berman BM, Lao L. IL-1ra alleviates inflammatory hyperalgesia through preventing phosphorylation of NMDA receptor NR-1 subunit in 

rats. Pain, April 2008; 135(3):232-9. Epub Aug. 

6, 2007. PMID: 17689191.

Zhang RX, Li A, Liu B, Wang L, Ren K, Qiao 

JT, Berman BM, Lao L. Electroacupuncture 

attenuates bone cancer pain and inhibits spinal 

interleukin-1 beta expression in a rat model. 

Anesthesia and Analgesia, November 2007; 

105(5):1482-88. PMID: 17959986.

Publication from Featured Research 

**Tang Y, Simoneau AR, Xie J, Shahandeh B, 

Zi X. Effects of the kava chalcone flavokawain 

A differ in bladder cancer cells with wild-type 

versus mutant p53. Cancer Prevention Research, 

November 2008; 1(6):439-51. (From page 47, 

Kava Root Compound Shows Promise for the 

Prevention of Bladder Cancer) 

66 N C I C A M A N N U A L R E P O R T 2 0 0 8 
Appendix 

An NCI-sponsored 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 Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Pediatric Trials 

Phase III Randomized Study of a 

Therapeutic Music Video Intervention 

Versus Listening and Discussing 

Books on Tape for Increased Resilience 

and Quality of Life of Adolescents 

and Young Adults Undergoing 

Myeloablative Autologous or 

Allogeneic Transplantation for Cancer 

COG-ANUR0631 Educational/ 

Counseling/Training 

11 to 24 NINR; NCI Phase III 

Phase III Randomized Study of 

Glutamic Acid in Reducing 

Vincristine-Related Peripheral 

Neurotoxicity in Young Patients 

Undergoing Vincristine-Containing 

Treatment for Wilms’ Tumor, 

Rhabdomyosarcoma, Acute 

Lymphoblastic Leukemia, or 

Non-Hodgkin’s Lymphoma 

HLMCC-0402 Supportive care; 

Treatment 

3 to 20 NCI Phase III 

Phase I Study of Beta-Glucan and 

Rituximab in Pediatric Patients with 

Relapsed or Progressive CD20­

Positive Lymphoma or Leukemia or 

Post-Allogeneic Stem Cell TransplantRelated Lymphoproliferative Disorder 

MSKCC-03095 Treatment Under 22 NCI Phase I 

Phase I Study of Beta-Glucan and 

Monoclonal Antibody 3F8 in Patients 

with Metastatic Neuroblastoma 

MSKCC-05073 Treatment; Biomarker/ 

Laboratory analysis 

Any age NCI Phase I 

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 Prevention; Educational/ 11 to 14 

Counseling/Training 

NCI No phase specified 

A P P E N D I X 67 
68 N C I C A M A N N U A L R E P O R T 2 0 0 8 

PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Pediatric Trials 

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 Supportive care 5 to 35 NCCAM; NCI No phase specified 

Adult Trials 

Bladder 

Phase II Randomized Study of 

Neoadjuvant Genistein in Patients 

Undergoing Surgical Resection for 

Bladder Cancer 

WCCC-CO-04307 Biomarker/Laboratory 

analysis; Treatment 

18 and over NCI Phase II 

Phase II Randomized Study of 

Neoadjuvant Polyphenon® E 

(Defined Green Tea Catechin Extract) 

in Patients with Nonmetastatic 

Bladder Cancer 

WCCC-UWI06-8-01 Treatment; Biomarker/ 

Laboratory analysis 

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 Treatment 18 and over NCI Phase II 

Pilot Study of a Stress Reduction 

Program in Patients with Malignant 

Brain Tumors and Their Family 

Caregivers 

CASE-CCF-2306-CC052 Supportive care 18 and over NCI No phase specified 

Breast 

Phase III Randomized Study of the 

Effects of Dietary Soy on Estrogens 

in Breast Fluid, Serum, and Urine 

Samples from Healthy Women 

UHM-CHS-4116 Prevention; Biomarker/ 

Laboratory analysis 

30 to 45 NCI Phase III 

Phase II Randomized Study of 

Genistein in Women at High Risk 

for Breast Cancer 

NU-NWU03-1-04 Prevention 25 and older NCI Phase II 

Phase II Randomized Study of Soy 

Protein in Postmenopausal Women 

with Breast Disease Taking Tamoxifen 

and Experiencing Hot Flashes 

CALGB-79805 Supportive care Postmenopausal

(20 and over) 

NCI Phase II 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials

Breast

Phase II Study of Hypericum 

Perforatum (St. John’s wort) in 

Postmenopausal Women with 

Non-Metastatic Breast Cancer 

Suffering from Hot Flashes 

CCCWFU-98301 Supportive care 18 and over NCI Phase II 

Phase II Randomized Study of 

Three Different Programs of Paced 

Breathing in Women with Hot Flashes 

MAYO-MC06C8 Supportive care 18 and over NCI Phase II 

Phase II Randomized Study of 

Acupuncture Versus Standard-ofCare Analgesics in Reducing Pain 

in Post-Menopausal Women with 

Breast Cancer and Aromatase 

Inhibitor-Associated Arthralgia 

UARIZ-07-0792-04 Supportive care; 

Biomarker/Laboratory 

analysis 

Not specified NCI Phase II 

Phase II Randomized Study of 

Acupuncture in Reducing 

Musculoskeletal Symptoms in Women 

Receiving Aromatase Inhibitors for 

Stage 0-III Breast Cancer 

JHOC-J07110 Supportive care; 

Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI Phase II 

Phase II Study of Gemcitabine 

Hydrochloride and Genistein in 

Women with Stage IV Breast Cancer 

WSU-C-2597 Treatment 18 and over NCI Phase II 

Phase II Randomized Study of 

Omega-3 Fatty Acids in Women 

with Newly Diagnosed Ductal 

Carcinoma In Situ and/or Atypical 

Ductal Hyperplasia 

OHSU-3872 Treatment; Biomarker/ 

Laboratory analysis 

Over 21 NCI Phase II 

Phase I/II Randomized Study of 

Physical Activity Versus Usual Care 

in Preventing Weight Gain in Women 

with Newly Diagnosed Stage I or II 

Breast Cancer Undergoing Adjuvant 

Chemotherapy 

FCCC-FCRB-05-009 Supportive care 18 and over NCI Phase I; Phase II 

Phase I Pilot Chemoprevention Study 

of IH636 Grape Seed Proanthocyanidin 

Extract in Healthy Postmenopausal 

Women at High Risk of Developing 

Breast Cancer 

CHNMC-IRB-03178 Prevention 40 to 75 NCI Phase I 

Phase I Study of White Button 

Mushroom Extract in Preventing 

the Recurrence of Breast Cancer 

in Postmenopausal Women Who 

Are Breast Cancer Survivors 

CHNMC-07213 Treatment; Biomarker/ 

Laboratory analysis 

21 and over NCI Phase I 

A P P E N D I X 69 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Breast

Phase I Randomized Study of Green 

Tea Catechin Extract (Polyphenon E) 

in Women with a History of Hormone 

Receptor-Negative Stage I-III Breast 

Cancer 

MDA-MDA04-4-01 Treatment; Prevention; 

Biomarker/Laboratory 

analysis 

21 to 65 NCI Phase I 

Pilot Study of Standardized FreezeDried Table Grape Powder on 

Plasma Estrogen Levels in 

Postmenopausal Women Participating 

in the Mayo Mammography 

Health Study 

MAYO-MC0536 Biomarker/Laboratory 

analysis; Prevention 

18 and over NCI No phase specified 

Randomized Pilot Study of Flaxseed 

in Premenopausal Women at Risk 

of Developing a Primary Breast Cancer 

RPCI-I-81906 Prevention; Biomarker/ 

Laboratory analysis 

21 to 50 NCI No phase specified 

Randomized Study of the Effect 

of a Reduced-Calorie Diet and/or 

Exercise Program on Risk Factors 

for Breast Cancer Development in 

Overweight or Obese Postmenopausal 

Women 

FHCRC-PHS-1960.00 Prevention; Biomarker/ 

Laboratory analysis; 

Behavioral study 

50 to 75 NCI No phase specified 

Randomized Study of Exercise in 

Preventing Breast Cancer in Healthy 

Young Women 

UMN-0505M69867 Prevention; Diagnostic 18 to 30 NCI No phase specified 

Randomized Pilot Study of Hypnosis 

in Controlling Hot Flashes in Women 

Who are Breast Cancer Survivors 

S-WHITE-8165 Supportive care Over 18 NCI No phase specified 

Randomized Pilot Study of the Effect 

of Healing Touch in Women with 

Breast Cancer Experiencing 

Radiotherapy-Induced Fatigue 

VU-VICC–SUPP-0633 Supportive care 21 to 75 NCI No phase specified 

Pilot Study of Pre-Operative Hypnosis 

to Reduce Post-Operative Pain and 

Anesthesia-Related Side-Effects in 

Women Undergoing Surgery for 

Breast Cancer 

CHNMC-08029 Supportive care 18 and over NCI No phase specified 

Randomized Pilot Study of the 

Mindful Movement Program in 

Older Female Breast Cancer Survivors 

CHNMC-08061 Supportive care 50 and over NCI No phase specified 

Randomized Study of Hatha Yoga in 

Improving Physical Activity, 

Inflammation, Fatigue, and Distress 

in Female Breast Cancer Survivors 

OSU-2007C0004 Supportive care; 

Biomarker/Laboratory 

analysis 

21 and over NCI No phase specified 

70 N C I C A M A N N U A L R E P O R T 2 0 0 8 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Breast

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 Supportive care; 

Treatment 

18 and over NCI No phase specified 

Randomized Pilot Study of 

Neoadjuvant Therapy Comprising 

Flaxseed and/or Anastrozole in 

Postmenopausal Women Undergoing 

Surgery for Newly Diagnosed, 

Estrogen Receptor-Positive, Stage I 

or II Breast Cancer 

RPCI-I-99507 Treatment; Biomarker/ 

Laboratory analysis 

18 to 85 NCI No phase specified 

Cervix 

Phase II Randomized Study of 

Green Tea Extract (Polyphenon E) 

for the Prevention of Cervical 

Cancer in Patients with Human 

Papillomavirus (HPV) and 

Low-Grade Cervical Intraepithelial 

Neoplasia (CIN 1) 

UARIZ-UAZ03-1-02 Prevention 18 and over NCI Phase II 

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 Prevention; Biomarker/ 

Laboratory analysis 

19 and over NCI Phase II 

Phase I Randomized Study of 

Leucine-Enhanced Essential Amino 

Acid Supplement and/or Testosterone 

for Cancer-Related Cachexia in 

Patients with Advanced or 

Recurrent Cervical Carcinoma 

UTMB-06073 Supportive care; 

Biomarker/Laboratory 

analysis 

18 to 59 NCI Phase I 

Randomized Study of MindfulnessBased Stress Reduction Versus 

General Health Education in 

Improving Immune Response to 

Human Papilloma Virus in Patients 

with Cervical Dysplasia 

FCCC-06851 Behavioral study; 

Educational/Counseling/ 

Training; Biomarker/ 

Laboratory analysis 

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 Natural history/ 

Epidemiology; 

Prevention 

50 and over NCI Phase III 

A P P E N D I X 71 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Colon/Rectum

Phase III Randomized Study of 

Selenium in Patients with 

Adenomatous Colorectal Polyps 

UARIZ-00-0430-01 Prevention 40 to 80 NCI Phase III 

Phase II Randomized 

Chemoprevention Study of 

Atorvastatin Versus OligofructoseEnriched Inulin (Raftilose Synergy 1) 

Versus Sulindac in Patients at 

Increased Risk of Developing 

Sporadic Colorectal Neoplasia 

MAYO-030103 Prevention; Biomarker/ 

Laboratory analysis 

40 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 Supportive care Over 18 NCI Phase II 

Phase I Study of Resveratrol in 

Patients with Resectable 

Colorectal Cancer 

CCUM-TASK2B Treatment; Biomarker/ 

Laboratory analysis 

Over 18 NCI Phase I 

Pilot Randomized Study of 

Cholecalciferol and Calcium 

Carbonate in Patients with Resected 

Colon Cancer 

RPCI-I-78706 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI No phase specified 

Esophagus 

Phase IB Randomized Study of 

Green Tea Extract (Polyphenon E) 

in Preventing Esophageal Cancer in 

Patients with Barrett’s Esophagus 

MDA-03101 Prevention 18 and over NCI Phase I 

Head and Neck 

Phase III Randomized Study of 

Acupuncture Versus Standard of 

Care in Treating Pain and Dysfunction 

in Patients with Head and Neck 

Cancer Who Have Undergone 

Neck Dissection 

MSKCC-03131A Supportive care Not specified NCI Phase III 

Phase II/III Randomized Study of 

Acupuncture-Like Transcutaneous 

Electrical Nerve Stimulation (ALTENS) 

Versus Pilocarpine Hydrochloride in 

Head and Neck Cancer Patients with 

Early Radiotherapy-Induced Xerostomia 

RTOG-0537 Supportive care 18 and over NCI Phase II; Phase III 

Phase II Randomized Study of Fruit 

and Vegetable Extracts in Patients 

with Stage I-IVB Head and Neck 

Cancer 

CCCWFU-0112 Treatment 18 and over NCI Phase II 

72 N C I C A M A N N U A L R E P O R T 2 0 0 8 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Head and Neck

Phase I Randomized Study of 

Antioxidant-Deficient Diet in 

Controlling Cachexia in Patients with 

Oropharyngeal Cancer Receiving 

Chemoradiotherapy 

UNC-LCCC-0523 Supportive care; 

Biomarker/Laboratory 

analysis; Treatment 

Over 18 NCI Phase I 

Randomized Pilot Study of 

Electroacupuncture for Chronic 

Radiation-Induced Xerostomia 

in Patients with Head and Neck Cancer 

MAYO-MCS285 Supportive care 21 to 89 NCI No phase specified 

Hematologic 

Phase III Randomized Study of 

American Ginseng Extract to Prevent 

Respiratory Infection and Reduce 

Antibiotic Use in Patients with 

Chronic Lymphocytic Leukemia 

CCCWFU-98308 Supportive care 18 and over NCI Phase III 

Phase I/II Study of Green Tea Extract 

(Polyphenon E) in Patients with 

Previously Untreated Stage 0-II 

Chronic Lymphocytic Leukemia 

MAYO-MC0419 Treatment 18 and over NCI Phase I; Phase II 

Lung 

Phase III Randomized 

Chemoprevention Study of 

Selenium in Participants with 

Previously Resected Stage I 

Non-Small Cell Lung Cancer 

ECOG-5597 Prevention 18 and over NCI Phase III 

Phase II Randomized Study of 

Defined Green Tea Catechin Extract 

in Former or Current Heavy Smokers 

with Abnormal Sputum Score 

BCCA-H03-61083 Prevention; Biomarker/ 

Laboratory analysis 

45 to 74 NCI Phase II 

Phase II Randomized Study of 

Green Tea or Polyphenon E in 

Preventing Lung Cancer in Former 

Smokers with Chronic Obstructive 

Pulmonary Disease 

UARIZ-HSC-0353 Prevention; Biomarker/ 

Laboratory analysis 

40 to 80 NCI Phase II 

Phase II Chemoprevention Study of 

Curcumin in Current Smokers with 

Aberrant Crypt Foci 

UCIRVINE-UCI04-2-01 Prevention; Biomarker/ 

Laboratory analysis 

40 and over NCI Phase II 

Phase II Randomized Study of 

Polyphenon E, A Defined Green 

Tea Catechin Extract, in Current or 

Former Smokers with Bronchial 

Dysplasia 

BCCA-H07-02401 Prevention; Biomarker/ 

Laboratory analysis 

45 to 74 NCI Phase II 

A P P E N D I X 73 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Lung

Phase I Pilot Study of Calcitriol in 

Smokers or Former Smokers with 

Squamous Metaplasia or Squamous 

Dysplasia of the Lungs 

RPCI-I-90206 Prevention; Biomarker/ 

Laboratory analysis 

40 to 79 NCI Phase I 

Phase I Study of Beta-Glucan 

MM-10-001in Patients with Locally 

Advanced or Metastatic Non-Small 

Cell Lung Cancer 

CHNMC-07243 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI; 

Pharmaceutical/ 

Industry 

Phase I 

Chemoprevention Study of Broccoli 

Sprout Extract in Smokers 

JHOC-J0427 Prevention Over 18 NCI No phase specified 

Multiple 

Pilot Randomized Study of CognitiveBehavioral Therapy Versus Standard 

Care in Patients with Advanced 

Gastrointestinal Cancer or Lung Cancer 

MGH-2007-P-000368 Educational/ 

Counseling/Training; 

Supportive care 

Over 18 NCI No phase specified 

Non-Cancer 

Phase I Randomized Study of 

Nutritional-Grade, AbsorptionEnhanced Diindolylmethane (BR-DIM) 

in Healthy Volunteers 

KUMC-HSC-9139-3 Biomarker/Laboratory 

analysis; Prevention 

18 to 70 NCI Phase I 

Phase I Study of Resveratrol in 

Healthy Adult Participants 

UARIZ-BIO-07-0376-04 Biomarker/Laboratory 

analysis; Prevention 

18 and over NCI Phase I 

Phase I Randomized Study of Garlic 

Supplements to Modulate Opioid 

Effects in Healthy Volunteers 

FHCRC-2040.00 Natural history/ 

Epidemiology; 

Biomarker/Laboratory 

analysis 

21 to 45 NCI Phase I 

Phase I Randomized Study of a 

New Formulation of Bowman-Birk 

Inhibitor Concentrate in Healthy 

Male Participants 

UPCC-805938 Prevention; Biomarker/ 

Laboratory analysis 

18 to 65 NCI Phase I 

Randomized Study of a PatientDirected Lifestyle Change and 

Health Promotion Program 

Versus Usual Care in Low-Income, 

Uninsured Participants in Los Angeles 

County, California 

UCLA-G-060801501A Behavioral study; 

Educational/Counseling/ 

Training; Health 

services research 

18 and over NCI No phase specified 

Pilot Study of a Combination 

Nutritional Supplement Capsule 

Containing Curcumin, Green 

Tea Extract, Polygonum cuspidatum 

Extract, and Soybean Extract in 

Healthy Participants 

WSU-2007-109 Biomarker/Laboratory 

analysis; Prevention 

18 and over NCI No phase specified 

74 N C I C A M A N N U A L R E P O R T 2 0 0 8 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Prostate 

Phase III Randomized Study of Soy 

Protein/Isoflavones and Venlafaxine 

on Vasomotor Symptoms in Patients 

with Prostate Cancer Undergoing 

Hormonal Manipulation 

CCCWFU-97405 Supportive care 21 and over NCI Phase III 

Phase III Randomized Study of 

Pomegranate Extract in Patients with 

Rising Prostate-Specific Antigen 

Levels After Surgery or Radiotherapy 

for Localized Prostate Cancer 

ROLL-GUP-0205-1 Treatment 18 and over NCI; 

Pharmaceutical/ 

Industry 

Phase III 

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 Treatment; Biomarker/ 

Laboratory analysis 

40 to 75 NCI Phase II; Phase III 

Phase II Randomized Chemoprevention 

Study of Calcitriol in Patients with 

High-Grade Prostatic Intraepithelial 

Neoplasia 

CINJ-080404 Prevention 18 and over NCI Phase II 

Phase II Randomized Pilot Study 

of Calcitriol and Dexamethasone 

Before Radical Prostatectomy in 

Patients with Localized 

Adenocarcinoma of the Prostate 

RPCI-RP-0212 Treatment 18 and over NCI Phase II 

Phase II Randomized Study of 

Different Doses of Cholecalciferol 

(Vitamin D) in Patients with 

Prostate Cancer 

RPCI-I-95406 Treatment 18 and over NCI Phase II 

Phase II Randomized Study of 

Selenium in Patients with 

Adenocarcinoma of the Prostate 

UARIZ-97-0395 Treatment; Biomarker/ 

Laboratory analysis 

Under 85 NCI Phase II 

Phase II Randomized Study of 

Neoadjuvant Dietary Supplementation 

with Soy in Patients Undergoing 

Radical Prostatectomy for Localized 

Prostate Cancer 

CCCWFU-98203 Treatment; Biomarker/ 

Laboratory analysis 

Over 18 NCI Phase II 

Phase II Study of Calcitriol and 

Dexamethasone in Patients with 

Androgen-Independent Prostate 

Cancer 

RPCI-I-65405 Treatment; Biomarker/ 

Laboratory analysis 

Not specified NCI Phase II 

A P P E N D I X 75 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Prostate

Phase II Randomized Study of 

Green Tea and Decaffeinated Black 

Tea Versus Water in Patients with 

Adenocarcinoma of the Prostate 

Scheduled to Undergo Prostatectomy 

UCLA-061109702 Treatment; Biomarker/ 

Laboratory analysis 

40 to 75 NCI Phase II 

Phase II Randomized Study of 

Neoadjuvant Lycopene 

Supplementation in Patients 

Undergoing Radical Prostatectomy 

for Prostate Cancer 

MDA-04-3-01 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI Phase II 

Phase II Randomized Study of 

Selenomethionine and Finasteride 

Prior to Prostatectomy or Bracytherapy 

in Patients with Stage I or II 

Prostate Cancer 

RPCI-I-104607 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI Phase II 

Phase II Randomized Study of 

Selenomethionine Supplementation 

in Patients Undergoing Prostatectomy 

or Brachytherapy for Stage I or II 

Prostate Cancer 

RPCI-I-104307 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI Phase II 

Phase I Study of Absorption-Enhanced 

Diindolylmethane (BioResponse-DIM) 

in Patients with Nonmetastatic, 

Hormone-Refractory Prostate Cancer 

and Rising Prostate-Specific 

Antigen Levels 

WSU-D-2979 Treatment 18 and over NCI Phase I 

Phase I Randomized Study of 

Neoadjuvant Diindolylmethane in 

Patients Undergoing Radical 

Prostatectomy for Stage I or II 

Adenocarcinoma of the Prostate 

WCCC-CO05186 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI Phase I 

Phase I Study of Defined Green Tea 

Catechin Extract in Patients with 

Prostate Cancer Scheduled to 

Undergo Prostatectomy 

UARIZ-UAZ05-6-01 Treatment; Biomarker/ 

Laboratory analysis 

18 and over NCI Phase I 

Phase I Study of White Button 

Mushroom Extract at Six Different 

Dose Levels in Patients with 

Biochemically Recurrent, HormoneNaive Prostate Cancer After 

Local Therapy 

CHNMC-08012 Treatment; Biomarker/ 

Laboratory analysis 

Not specified NCI Phase I 

Randomized Study of the Molecular 

Effects of Lycopene Versus Omega-3 

Fatty Acid Nutritional Supplements 

in Patients with Stage I or II 

Prostate Cancer 

UCSF-03553 Biomarker/Laboratory 

analysis; Treatment 

Not specified NCI No phase specified 

76 N C I C A M A N N U A L R E P O R T 2 0 0 8 
A P P E N D I X 

PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Prostate

Randomized Study of Fish Oil 

Supplements and Green Tea Extract 

in Preventing Prostate Cancer in 

Patients Who Are at Risk for 

Developing Prostate Cancer 

OHSU-CI-CPC-04131­

LX 

Prevention 18 and over NCI No phase specified 

Randomized Study of Lycopene in 

Preventing Prostate Cancer in 

Healthy Participants 

UIC-2004-0217 Prevention; Biomarker/ 

Laboratory analysis 

18 and over NCI No phase specified 

Study of Acupuncture in Treating 

Hot Flashes in Patients with Prostate 

Cancer Undergoing Androgen 

Deprivation 

OHSU-7235 Supportive care Over 18 NCI No phase specified 

Randomized Study of 

Polyunsaturated Fatty Acids in 

Patients with Prostate Cancer 

Undergoing Prostate Biopsy and/or 

Surgery 

DFCI-03116 Treatment; Biomarker/ 

Laboratory analysis 

Adult NCI No phase specified 

Ovarian 

Randomized Study of Hypnosis, 

Massage Therapy, and Healing 

Touch in Patients Undergoing 

Chemotherapy for Ovarian Epithelial 

or Primary Peritoneal Cavity Cancer 

UMN-2000NT790 Supportive care Any age NCI No phase specified 

Non-Specified 

Phase III Randomized Study of 

(Valerian) for Improving Sleep in 

Patients with Cancer Receiving 

Adjuvant Therapy 

NCCTG-N01C5 Supportive care 18 and over NCI Phase III 

Phase III Randomized Study of 

Levocarnitine (L-carnitine) for the 

Management of Fatigue in 

Cancer Patients 

ECOG-E4Z02 Supportive care 18 and over NCI Phase III 

Phase III Randomized Study of 

Alpha-Lipoic Acid in Preventing 

Platinum-Induced Peripheral 

Neuropathy in Cancer Patients 

Receiving a Cisplatin- or OxaliplatinContaining Chemotherapy Regimen 

MDA-CCC-0327 Supportive care Not specified NCI Phase III 

Phase III Randomized Study of 

Vitamin E in Preventing 

Chemotherapy-Induced Peripheral 

Neuropathy in Patients Undergoing 

Curative Neurotoxic Chemotherapy 

for Cancer 

NCCTG-N05C3 Supportive care 18 and over NCI Phase III 

77 
PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Non-Specified

Phase II/III Randomized Study of 

Ginger for Chemotherapy-Related 

Nausea in Patients with Cancer 

URCC-U1902 Supportive care 18 and over NCI Phase II; Phase III 

Phase II Randomized Study of a 

Multimedia Program About Massage 

Therapy for Cancer Patients and 

Their Care Partners 

COLLINGE-06-200 Educational/Counseling/ 

Training; Supportive 

care 

21 and over NCI Phase II 

Phase II Randomized Pilot Study of 

Massage Therapy in Patients with 

Cancer Pain 

MSKCC-03046A Supportive care 18 and over NCI Phase II 

Phase II Randomized Study of 

Ginger in Patients with Cancer and 

Chemotherapy-Induced Nausea 

and Vomiting 

CCUM-0201 Supportive care 18 and over NCI; NCCAM Phase II 

Phase II Randomized Study of 

Hatha Yoga for Persistent Sleep 

Disturbance in Cancer Survivors 

URCC-U3905 Supportive care 21 and over NCI Phase II 

Pilot Study of Psilocybin in Patients 

with Clinically Significant Depression 

or Anxiety Secondary to Cancer 

JHOC-J0647 Supportive care; 

Biomarker/ 

Laboratory analysis 

21 to 70 NCI Phase II 

Phase II Randomized 

Chemoprevention Study of 

Bowman-Birk Inhibitor Concentrate 

in Patients with Oral Leukoplakia 

UCIRVINE-UCI-98-34 Treatment; Prevention; 

Biomarker/ 

Laboratory analysis 

18 and over NCI Phase II 

Phase I/II Pilot Study of Genistein in 

Patients Undergoing Palliative 

External Beam Radiotherapy for 

Osseous Metastases 

UMN-2008LS035 Treatment 18 and over NCI Phase I; Phase II 

Phase I Study of High-Selenium 

Brassica Juncea in Combination 

with Irinotecan Hydrochloride and 

Capecitabine in Patients with 

Advanced Malignancies 

CHNMC-05122 Treatment 18 and over NCI Phase I 

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 Educational/ 

Counseling/Training 

18 and over NCI No phase specified 

Randomized Study of Stress 

Management Therapy in Patients 

Undergoing Chemotherapy for Cancer 

MCC-0501 Educational/ 

Counseling/Training; 

Supportive care 

18 and over NCI No phase specified 

78 N C I C A M A N N U A L R E P O R T 2 0 0 8 
A P P E N D I X 

PDQ Cancer CAM Clinical Trials Primary ID Type of Trial Age Range Sponsor of Trial Phase(s) 

Adult Trials 

Non-Specified

Randomized Study of Magnetic 

Acupressure in Reducing Pain in 

Cancer Patients Undergoing Bone 

Marrow Aspiration and Biopsy 

JHOC-J07103 Supportive care; 

Diagnostic 

18 and over NCI No phase specified 

Randomized Pilot Study of 

Glutamine Supplementation for the 

Prevention of Paclitaxel-Induced 

Myalgia and/or Arthralgia in 

Patients with Cancer 

OHSU-ONC-99037-L Supportive care 18 and over NCI No phase specified 

Pilot Study of Art Therapy 

Intervention for Caregivers of 

Pediatric Patients Undergoing 

Bone Marrow Transplantation for 

Cancer 

CHNMC-08028 Supportive care 18 and over NCI No phase specified 

Randomized Study of Resistance 

Exercise via Negative-Eccentric 

Work (RENEW) in Improving 

Mobility and Reducing Fatigue and/or 

Weakness in Elderly Cancer Survivors 

UUMC-R21CA114523 Supportive care 60 and over NCI No phase specified 

Randomized Study of an L-ArginineBased Nutritional Supplement 

(ArginMax®) in Female Cancer 

Survivors 

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

Randomized Study of the Effect of 

Animal-Assisted Therapy and 

Recreational Therapy on Distress 

in Cancer Patients Undergoing 

Treatment for Pain 

NCI-05-CC-0093 Supportive care; 

Biomarker/ 

Laboratory analysis 

18 and over NCI No phase specified 

79 
OCCAM Organizational Chart

National Cancer Institute 

Division of Cancer Treatment and 

Diagnosis 

Office of Cancer Complementary and 

Alternative Medicine 

Office of the Director 

Director

Administrative Program Specialist

Office Assistant

Health Science Administrator

Scientific Program Analysts

Interns and Fellows

Research Development and Support 

Program 

Director

Program Officer

Communications and Outreach Program 

Director

Program Coordinator

Program Analyst

Health Communications Intern

Practive Assessment Program 

Director

Program Coordinator

80 N C I C A M A N N U A L R E P O R T 2 0 0 8
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NIH Publication No. 10-7503 

Printed February 2010