Clinical trial NCT04155008
Conditions: Oncologic Complications Quality of Life Nutrition Poor Head and Neck Cancer Lung Cancer Pancreatic Cancer
Sponsor: Montefiore Medical Center
Start date: 2021-03-01; Completion date: 2021-04-05
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Loss of appetite is a common symptom of patients with cancer and can cause distress which impacts patients and caregivers. Patients diagnosed with head/neck, lung or pancreatic cancer will be recruited for this study to decrease the suffering and distress associated with eating during cancer treatment and improve the quality of life of patients by implementing an algorithm utilizing nutrition intervention and appetite stimulants.

Detailed description:

Arms: arm 1: The patients with fair-good appetite (score on CNAQ more than 24) will not receive any pharmacological agents and will receive nutrition intervention alone.

CNAQ = Council on Nutrition Appetite Questionnaire arm 2: The patients with poor-fair appetite (score on CNAQ less than 24) will be provided nutrition intervention by the Registered Dietitian and then put into one of three pharmacological groups.

CNAQ = Council on Nutrition Appetite Questionnaire
Interventions: intervention 1: Dexamethasone intervention 2: Dronabinol intervention 3: Mirtazapine intervention 4: Nutrition Intervention
Intervention descriptions: intervention 1: If the patient's prognosis is extremely poor (less than 12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (which is FDA approved), once daily, to be taken orally in the morning. intervention 2: If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (which is FDA approved) 2.5mg, twice daily before meals. intervention 3: If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (which is FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime. intervention 4: Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status

Protocol documents:
Prot_SAP_ICF_000.pdf: 
1
Assessing Quality of Life and the Feasibility of a Nutrition and 
Pharmacological Algorithm for Oncology Patients with Anorexia
CONFIDENTIAL
The information contained in this document is regarded as confidential and, except to the extent 
necessary to obtain informed consent, may not be disclosed to another party unless law or 
regulations require such disclosure. Persons to whom the information is disclosed must be informed 
that the information is confidential and may not be further disclosed by them.
Principal Investigators
Justin Tang, MD
Montefiore Medical Center
Department of Radiation Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-7750
Fax: 718-882-6914
Email: jtang@montefiore.org
Rachel Padilla, MS RD CDN
Montefiore Medical Center
Department of Medical Oncology and Radiation Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-6720 
Fax: 718-231-4225 
Email: rszalkie@montefiore.org
Co-investigators
Nitin Ohri, MD
 Albert Einstein College of Medicine 
Department of Radiation Oncology 
1300 Morris Park Avenue, Mazer 105 
Bronx, NY 10461 
Phone: 718-303-3143 
Fax: 718-430-8618 
Sadiya Lakhi, MS, AGNP-BC, RN
Albert Einstein College of Medicine 
Department of Radiation Oncology 
1300 Morris Park Avenue, Mazer 105 
Bronx, NY 10461 
Phone: 718-920-7750 
Fax: 718-430-8618 
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2
Marlene McHugh, NP
Montefiore Medical Center
Department of Palliative Care 
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-6378
Fax: 718-881-6054
Lauretta Kahn, NP
Montefiore Medical Center
Department of Medical Oncology 
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-4982
Fax: 718-547-6907
Andreas Kaubisch, MD
Montefiore Medical Center
Department of Medical Oncology 
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-4057
Fax:718-547-6907
Jennifer Chuy, MD
Montefiore Medical Center
Department of Medical Oncology 
111 East 210th Street
Bronx, NY 10467
Phone: 718-920-9168
Fax: 718-547-6907
Co-Investigators (Statistics)
Shankar Viswanathan, DrPH, MSc
Albert Einstein College of Medicine
1300 Morris Park Avenue, Belfer 1312D
Bronx, New York 10461
Phone: 718-430-3762
Fax: 718-430-8780
Research Coordinator
Michelle Goggin
Montefiore Medical Center
Department of Radiation Oncology
111 East 210th Street
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3
Bronx, NY 10467
Phone: 718-629-7743
Fax: 718-231-5064
ema
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Assessing Quality of Life and the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology 
Patients With Anorexia
1.0 BACKGROUND 
1.1 Background and Significance
Cancer is one of the leading causes of death in the United States, accounting for nearly one out of every 
four deaths each year. According to the American Cancer Society, the lifetime risk for developing cancer is 
approximately one in three for women and one in two for men; of those diagnosed, one in four men and one in 
five women will ultimately die.1
Cancer patients are particularly vulnerable to nutritional depletion as a result of the joint impact of the 
malignant disease process and its treatment.2 The frequency of weight loss and malnutrition in oncology 
patients has been estimated to range from 31 to 87 percent.3 Among most types of cancer, weight loss has been 
associated with a decreased ability to perform activities of daily living (ADLs), and even a six percent weight 
loss has been found to predict a diminished response to treatment, survival, and quality of life.4  Weight change 
and associated performance status are important, as they can potentially influence decisions about modality, 
dosage, and timing of treatment(s).
Malnutrition has been given the definition of "a state of nutrition in which a deficiency or excess (or 
imbalance) of energy, protein, and other nutrients causes measurable adverse effects on tissue/body form (body 
shape, size and composition) and function and clinical outcome."5 Many studies examining the consequences of 
malnutrition in the oncology population have revealed increased morbidity and mortality rates when compared 
to well-nourished patients.6  It has been proposed that cancer patients often die from malnutrition and its related 
complications rather than from the direct effects of the disease itself.7  Thus, the identification of oncology 
patients at nutritional risk and implementation of nutritional intervention is critical to ultimately reduce cancer 
morbidity and mortality.8 
In addition to malnutrition, the oncology population often suffers from a cachexia syndrome. Cancer 
cachexia is a term which is given to patients who have ongoing loss of skeletal muscle mass, insulin resistance, 
along with other nutritional and medical abnormalities. It is characterized by an “ongoing loss of skeletal 
muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support 
and leads to progressive functional impairment”.9 Typically, cachexia is first seen when a patient experiences 
anorexia. The consequence of the anorexia can affect the patient and caregivers in many different ways 
including, physical, psychological, social, and existentially. The patients and caregivers often feel negative 
emotions with regards to cachexia and malnutrition.10 Some of these negative emotions are described as 
“sadness, disappointment, bewilderment, confusion, bother, concern, dissatisfaction, feeling upset, anger, 
frustration, guilt, desperation, anguish, fear, anxiety, and existential distress”.11 This stress is not only on the 
oncology patient but the caregiver as well. 
There is no single cause of the symptoms associated with cancer cachexia despite years of research. 
Along with the causes, there is not one particular treatment plan for this syndrome. Jointly there are three main 
interventions which are pertinent in treating and managing cancer cachexia. These are antitumor treatment, 
nutrition intervention, and pharmaceutical intervention. 
Nutrition assessment and intervention of patient is one of the most crucial steps in a patient’s care. 
Nutritional assessment of cancer patients can reveal mild or moderate states of malnutrition before the patient 
becomes visibly wasted.12-18 With in-depth nutritional assessment, performed by an RD or medical professional, 
the presence of symptoms that may adversely affect nutritional status is documented, which enables the 
planning of appropriately individualized interventions. Early and intensive nutrition intervention provides 
beneficial outcomes in terms of positive impact on nutrition status, physical function, quality of life, weight 
maintenance, and overall survival in oncology patients. Poor nutritional status at baseline is associated with 
worse outcomes that may aggravate from both disease course and its treatments, thus oncology patients at risk 
for malnutrition should receive early, regular and individualized nutrition intervention and support.19-23 
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Many pharmacological agents have been studied in order to help prevent deterioration of patients. 
However, many of the results remain variable. Some studies have found there may be a benefit in terms of 
appetite but limited increase in lean body mass and continued weight loss in patients despite medicine 
administration. However, overall improved quality of life (QOL) may be possible for these patients. There is 
not currently one pharmacologic agent which has been proven to be beneficial for the general oncology 
population.24 
With anorexia being a major symptom of cancer cachexia and the psychological stress which impacts 
the patient and caregivers, and limited research showing the benefit of both nutrition intervention and 
pharmacological agents on overall survival and lean body mass, our goal to is focus on decreasing the suffering 
and distress associated with eating in our patients.
2.0 AIMS
2.1 Aim 1

To establish the feasibility of implementing an algorithm for nutrition interventions in our 
Cancer Center
2.2 Aim 2

To assess associations between appetite scores and general quality of life measures in cancer 
patients. 
3.0 METHODS/DESIGN
The patients must fulfill the following inclusion criteria prior to entering the study. 
3.1 Inclusion Criteria
1. Patients with a diagnosis of head/neck, lung, pancreatic cancer, or metastatic disease of any 
solid primary malignancy 
2. Planned, ongoing, or recently treated patient (within the past 30 days) with radiation therapy, 
chemotherapy, immunotherapy, and/or intravenous targeted biologic therapy
3. No previous use of appetite stimulants (steroid use for purposes other than appetite stimulant 
is allowed)
4. All patients must sign study specific informed consent prior to being included in the study
5. No contraindication to appetite stimulants
4.0 METHODS/DESIGN
4.1 Patient Selection
Patients with head/neck, lung, pancreatic cancer or metastatic disease of any solid primary 
malignancy will be screened for the study using the Oncology Nutrition Assessment which is currently 
the Standard of Care in the Montefiore Einstein Center for Cancer Care (Appendix 1).  The patients will 
then be informed regarding the study and decide to join or not. The patients who wish not to be included 
will be asked as to why if open to answer. 
4.2 Study Design
Appetite Assessments
This study will utilize the validated Council of Nutrition appetite questionnaire (CNAQ) 
(Appendix 2) to evaluate the effect of the nutrition intervention and pharmacological agents on patients’ 
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appetite and nutritional intake. The CNAQ has been used in many studies as a validated questionnaire to 
assess appetite. The patient populations in these studies have ranged from community-dwelling adults 
and nursing home residents to patients with chronic diseases like ALS.25-26 It has also been used as a 
validated analysis of appetite in studies with patients with liver cancer in Taiwan and head and neck 
cancer. 27-28
The patients will fill out this questionnaire weekly to assess change. If the patient scores >28 on 
the CNAQ, then the questionnaire will be administered biweekly, as will the nutrition education. 
Quality of Life Assessments
All participants will also be asked to complete a quality of life survey (Functional Assessment of 
Cancer Therapy-General Population (FACT-GP), Appendix 3) on a weekly or biweekly basis at the 
same time as the nutrition assessment. If a patient is not present in the Medical Oncology or Radiation 
Therapy at the time either assessment is due, the assessments will be performed over the phone. 
FACT-GP measures quality of life by asking about physical, function, emotional, and social 
wellbeing. In its creation, the questionnaire was modified to so it can be applicable to the general cancer 
population. It has been used to assess quality of life in many different sites of cancer. 29-33
Nutritional Status
Nutritional status will be determined based on the answers to the appetite assessment and quality 
of life questionnaire, as well as the nutrition assessment provided by the Registered Dietitian. No lab 
values will be used to assess nutrition status during the course of this study.
Algorithm
The patient care will follow a pathway based on their responses to the CNAQ and clinical 
judgment of the physician and dietitian. The patients with fair-good appetite (score on CNAQ >24) will 
not receive any pharmacological agents and will receive nutrition intervention alone. Nutrition 
intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The 
intervention will involve “purposefully planned action(s) designed with the intent of changing a 
nutrition-related behavior, risk factor, environmental condition, or aspect of health status” 34.
The patients with poor-fair appetite (score on CNAQ <24) will be provided nutrition intervention 
by the Registered Dietitian and then put into one of three pharmacological groups. If the patient’s 
prognosis is extremely poor (<12 weeks expected survival, based on discussion with the patient’s 
treating physicians) and there is no additional disease modifying therapy planned, the patient will be 
prescribed 4mg dexamethasone (which is FDA approved), once daily, to be taken orally in the morning. 
Dexamethasone is given to patients with a limited expected lifespans because it has been found to be 
effective on a short-term basis. Also, the long-term usage of steroids has been found to myopathy and 
other various side effects. 35
If a patient has a history of marijuana use or has tried it in the past, then he/she will be prescribed 
medical marijuana based on financial availability due to previous exposure exhibiting better tolerance to 
the drug.  If the marijuana is not feasible, he or she will be prescribed dronabinol (which is FDA 
approved). Dronabinol is used as a substitute as it is contains synthetic delta-9-tetrahydrocannabinol 
(THC), a substrate of marijuana and therefore has a similar affect to medical marijuana. Since 
dronabinol is compounded similarly to medical marijuana, then for this patient population the tolerance 
to the medication is likely to be good. 36-38
If the patient does not have any history of marijuana use, mirtazapine will be prescribed. 
Mirtazapine has been show to improve both appetite and quality of like in cancer patients. 39-41 Dosing 
mirtazapine was determined by guidelines published by the US Department of Veterans Affairs/Department 
of Defense. If the patient is under the age of 70, then she/he would be prescribed 15mg of mirtazapine 
(which is FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the 
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patient is over the age of 70), then she/he would be prescribed 7.5mg of mirtazapine, once daily to be 
taken orally at bedtime. 
 Refer to the flowchart (Appendix 4) for the sample pathway.  
Study Duration
The study period will begin after the initial screening and immediately following study 
registration and last for three months. 
4.3 Primary Study Endpoint
The primary endpoint of this study is assessing the impact on quality of life for the oncology 
patients by using an algorithm for nutrition intervention and appetite stimulants.
4.4  Exploratory Secondary Study Endpoints

Hydration administration in the clinics

Emergency Room visits

Hospital admissions and days spent in the hospital
5.0 STATISTICAL CONSIDERATIONS
Primary Endpoint:
The primary endpoint of the study is administration of the appropriate nutrition/pharmaceutical 
intervention, as defined by our algorithm, within 30 days of study enrollment. A secondary and exploratory 
endpoint is to assess associations between appetite scores and general quality of life measures.
 
Statistical Analysis:
Descriptive statistics (eg: counts, percentages) will be used to report each of the following measures:

number of potential subjects screened

number of potential subjects who met inclusion criteria

number of subjects consented/enrolled

study subject demographics

number of subjects completing baseline assessments

number of subjects receiving nutritional intervention following the study algorithm

number dropped out will be presented as frequency counts and percentages along with their 95% 
confidence intervals
Associations between appetite scores and quality of life will be examined using analysis of variance (for 
continuous scale variables) and Cochran Mantel Haenzsel testing (for categorical variables).  Changes in 
quality of life scores over time will be examined using covariance pattern models or linear mixed models, as 
appropriate.
 
Sample Size Justification:
This is a pilot study to examine the feasibility of implementing our nutritional intervention algorithm in 
the study population. We have based the sample size on precision in estimating the rate of feasibility. We 
hypothesize that we will be successful in implementing the algorithm in 85% of the study population.  We 
will recruit a total of 30 participants, which would produce a 95% confidence interval around our point 
estimate of the feasibility rate whose width is 28% (i.e. 67% to 95%), based on the exact (Clopper-Pearson) 
formula.
Exploratory Secondary Endpoints:
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Descriptive statistics will be utilized to characterize quality of life measures over time for study subjects 
and to characterize the frequency of outpatient IV fluid hydration episodes, Emergency Room visits, and 
hospital admissions in study subjects.
6.0  REGULATORY CONSIDERATIONS
6.1 Protection of Human Subjects
The Investigator must ensure that patients or their legally acceptable representatives are clearly 
and fully informed about the purpose, potential risks and other critical issues regarding clinical trials in 
which they volunteer to participate.  Preparation of the consent form is the responsibility of the 
Investigator and must include all elements required by CFR 21 Part 50.25 and the local IRB.
6.2  Compliance with the Protocol and Protocol Revisions
The study must be conducted as described in this approved protocol.  All revisions to the 
protocol must be provided to the PI.  The PI should not implement any deviation or change to the 
protocol without prior review and documented approval/favorable opinion from the IRB/IEC of an 
Amendment, except where necessary to eliminate an immediate hazard(s) to study patients.
The investigator must ensure that patients or their legally acceptable representatives are clearly 
and fully informed about the purpose, potential risks and other critical issues regarding clinical trials in 
which they volunteer to participate.  Preparation of the consent form is the responsibility of the PI.
6.3 Registration and Enrollment 
All patients will be registered through the Clinical Trials Office at Montefiore Medical Center. 
On Study Form and the signed Patient Consent Form must be emailed to the clinical trials office at 
Montefiore Medical Center, cpdmuregistration@montefiore.org, at the time of registration and prior to 
patient treatment. At the same time, patient will be registered into the Velos system at 
ctms.montefiore.org. Recruitment will occur during standard of care visits by the treating physician. At 
the time of registration, all eligibility criteria must be checked. Patients must meet all of the eligibility 
requirements listed in Section 3.1. Data collection must not start prior to registration. It is the study 
coordinator’s responsibility to review all data submitted to Velos and the Clinical Trials Office for 
accuracy and completeness, and he/she must sign off on the study form.
7.0  DATA HANDLING AND RECORD KEEPING
7.1 Confidentiality
Information about study subjects will be kept confidential and managed according  to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those 
regulations require a signed subject authorization informing the subject of the following:

What protected health information (PHI) will be collected from subjects in this study

Who will have access to that information and why

Who will use or disclose that information

The rights of a research subject to revoke their authorization for use of their PHI.

In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  
For subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled 
study period.
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7.2 Source Documents
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are 
contained in source documents   Examples of these original documents, and data records include: 
hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, copies or 
transcriptions certified after verification as being accurate and complete, microfiches, photographic 
negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the 
laboratories, and at medico-technical departments involved in the clinical trial.
7.3 Data Safety Monitoring
As this is not a therapeutic trial, regular review of study conduct, adverse events, and results by a 
Data Safety and Monitoring Board is not required.
7.4 Data Recording
An excel spreadsheet will be used to record the CNAQ score, FACT-GP score, date of 
assessment and medication provided for each visit. 
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KEY INFORMATION FOR ASSESSING QUALITY OF LIFE AND THE FEASIBILITY OF A NUTRITION AND 
PHARMACOLOGICAL ALGORITHM FOR ONCOLOGY PATIENTS WITH ANOREXIA
We are asking you to choose whether or not to volunteer for a research study about nutrition education with regards to a 
low or decreased appetite and its and an appetite’s stimulant’s effect on your quality of life. This page is designed to give 
you key information to help you decide whether to participate. We have included detailed information after this page. Ask 
the research team questions. If you have questions later, the contact information for the research investigator in charge of 
the study is below.  
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?  
The goal of this study is to decrease the suffering and distress associated with eating during cancer treatment. Loss of 
appetite is a common symptom and can cause distress which impacts patients and caregivers so this study’s goal is to 
reduce the stresses and improve the quality of life of the patient. There is no one medicine which has been proven to be 
to help the general cancer population in terms of appetite, so this study has a pathway to potentially help improve the 
patient’s quality of life and appetite. By doing this study, we hope to learn about ways to improve patient’s quality of life. 
Your participation in this research will last 3 months.  
WHAT ARE THE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
You are being asked to participate in this study because you were screened by a nursing assessment, which indicated a 
need to be seen by a Registered Dietitian. For a complete description of benefits, refer to the Consent Document below.
WHAT ARE THE KEY REASONS YOU MIGHT NOT CHOOSE TO VOLUNTEER FOR THIS STUDY?
You may not want to participate in this study because you will have to fill out a questionnaire weekly or biweekly while 
undergoing your treatment and afterwards. For a complete description of risks, refer to the Consent Document below.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, 
benefits or rights or access to care you would normally have if you choose not to volunteer. 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS, OR CONCERNS?
The person in charge of the study is Rachel Padilla. If you have questions, suggestions, or concerns regarding this study 
or you want to withdraw from the study her contact information is 718-920-6720.
If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact staff in the 
Einstein Institutional Review Board (IRB) between the business hours of 9am and 5pm EST, Monday-Friday at 718-430-
2253 or irb@einstein.yu.edu
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11
MONTEFIORE MEDICAL CENTER
DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION
Introduction
You are being asked to participate in a research study called Assessing Quality of Life and 
the Feasibility of a Nutrition and Pharmacological Algorithm for Oncology Patients With 
Anorexia. Your participation is voluntary -- it is up to you whether you would like to 
participate. It is fine to say “no” now or at any time after you have started the study. If you 
say “no,” your decision will not affect any of your rights or benefits or your access to care.
The researcher in charge of this project is 
called the “Principal Investigator.” Her name is 
Rachel Padilla. You can reach Mrs. Padilla at: 
Office Address: 
111 East 210th Street
Bronx, NY, 10467
Telephone #: (718) 920-6720
For questions about the research study, or if 
you believe you have an injury, contact the 
Principal Investigator or the IRB.
The Institutional Review Board (IRB) of 
the Albert Einstein College of Medicine 
and Montefiore Medical Center has 
approved this research study. The IRB # 
is in the stamp in the upper right hand 
corner. If you have questions regarding 
your rights as a research subject you 
may contact the IRB office at 718-430-
2253, by e-mail at irb@einstein.yu.edu, 
or by mail:
Einstein IRB 
Albert Einstein College of Medicine
1300 Morris Park Ave., Belfer Bldg 
#1002
Bronx, New York 10461
Why is this study being done? 
The goal of this study is to decrease the suffering and distress associated with eating during 
cancer treatment. Loss of appetite is a common symptom and can cause distress which 
impacts patients and caregivers so this study’s goal is to reduce the stresses and improve 
the quality of life of the patient. There is no one medicine which has been proven to be to 
help the general cancer population in terms of appetite, so this study has a pathway to 
potentially help improve the patient’s quality of life and appetite.
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12
Why am I being asked to participate? 
You are being asked to participate in this study because you were screened by a nursing 
assessment, which indicated a need to be seen by a Registered Dietitian. Patients with a 
diagnosis of head/neck, lung, pancreatic cancer, or metastatic disease of any solid primary 
cancer with planned, ongoing, or were recently treated (within the past 30 days) with 
radiation therapy, chemotherapy, immunotherapy, and/or intravenous targeted biologic 
therapy are included in this study. Also, no previous use of appetite stimulants and no 
contraindication to appetite stimulants are included in this study. Approximately 30 patients 
are going to be enrolled in this study. This study is only taking place at the Moses Campus 
of Montefiore Einstein Center for Cancer Care.
All patients must sign study specific informed consent prior to being included in the study 
and have no contraindication to appetite stimulants.
How many people will take part in the research study?
You will be one of about 30 people who will be participating in this study. 
How long will I take part in this research?
It will take you about 3 months to complete this research study.  During this time, we will ask 
you to make at least one visit to Montefiore Medical Center.
What will happen if I participate in the study?  
Your appetite will be assessed initially by a validated Council of Nutrition Appetite 
Questionnaire. After which, you will either receive nutrition counseling alone or nutrition 
counseling with an appetite stimulant. The questionnaire will be given weekly if your appetite 
is poor. If it is fair or good, then the questionnaire will be given biweekly, as will the nutrition 
education. You will also receive quality of life survey on a weekly or biweekly basis at the 
same time as the nutrition assessment. If your appetite is found to be poor, then you will be 
given one of four possible appetite stimulants. The possible appetite stimulants are: medical 
marijuana or marinol, mirtazapine, and dexamethasone. 
 The study will begin after the initial screening and immediately following study registration 
and last for three months
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As part of this study we will review your medical records and put the information we collect 
in our research records.
Information Banking (Future Use and Storage)
We will store information about you in a “bank”, which is a library of information from many 
studies. This information cannot be linked to you. In the future, researchers can apply for 
permission to use the information for new studies to prevent, diagnose, or treat disease, 
including genetic research. Your information may be kept for a long time, perhaps longer 
than 50 years. If you agree to the future use, some of your de-identified genetic and health 
information (not linked to you) may be placed into one or more scientific databases. These 
may include databases maintained by the federal government.
You can choose not to participate in the bank and still be part of the main study and this 
will not affect your treatment at this facility.
INITIAL ONE (1) OF THE FOLLOWING OPTIONS
_______ I consent to have my information used for future research studies.
________ I do NOT consent to have my information used for future research studies. 
Information about me will be kept as long as required by regulations and institutional 
policy, but will not be used for future studies.
Will I be paid for being in this research study? 
You will not receive any payment or other compensation for taking part in this study.
Some researchers may develop tests, treatments or products that are worth money. You will 
not receive payment of any kind for your specimens and information or for any tests, 
treatments, products or other things of value that may result from the research.
Will it cost me anything to participate in this study? 
If you take part in this study, you or your insurance will pay for the appetite stimulant which 
is most appropriate for you. 
What will happen if I am injured because I took part in this study?
Unfunded Research
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If you are injured as a result of this research, only immediate, essential, short-term medical 
treatment as determined by the participating hospital, will be available for the injury without 
charge to you personally. 
•
No monetary compensation will be offered. 
•
You are not waiving any of your legal rights by signing this informed consent 
document. 
•
If additional treatment is required as a result of a physical injury related to the 
research, necessary medical treatment will be provided to you and billed to your 
insurance company or to you as part of your medical expenses.
Immediately report any discomforts, problems or injuries you experience during the course 
of your participation in the study to Rachel Padilla, 718-920-6720
What else do I have to do?

You must tell the research study doctor about any past and present diseases or 
allergies you are aware of and about all medications you are taking including “over-
the-counter” remedies and nutritional supplements or herbs.

If you do not feel well at any time, call your doctor or the research study doctor 
immediately. 

If you think you have become pregnant, contact your research study doctor 
immediately. 

If any other doctor recommends that you take any medicine, please inform him/her 
that you are taking part in a research study. You should give the other doctor the 
research study doctor’s name and phone number.

You may carry out all your normal daily activities.
Confidentiality
The researchers and study staff follow federal and state laws to protect your privacy. This 
part of the consent form tells you what information about you may be used and shared in the 
research described in this form. You do not have to sign this form but, if you do not, you may 
not participate in the research. 
The health information that we may use or disclose for the research described in this form 
includes information from your entire medical record, such as your name, phone number, 
email, medical diagnoses, dates, test results, social security number, medical record 
numbers, etc. 
Your information and research records will be kept confidential. Your study information will 
be kept as long as they are useful for the research described in this form.
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15
The only people who can see your research records are:

Researchers and other individuals who work with the researchers

Organizations and institutions involved in this research, including those that fund the 
research, if applicable

Groups that review research such as central reviewers, Institutional Review Boards, 
the Office for Human Research Protections, the US Food and Drug Administration,  
data coordinating centers, and domestic and foreign agencies that regulate 
research.
The purposes of these uses and disclosures are to (1) conduct the study and (2) make sure 
the study is being done correctly. The information covered under this form may no longer be 
protected by federal privacy laws (such as HIPAA) once disclosed, and those persons who 
receive your health information may share your information with others without your 
additional permission. All of these groups have been asked to keep your information 
confidential. 
To maintain the integrity of this research study, you generally will not have access to your 
research-related personal health information. If it is necessary for your care, your research-
related health information will be provided to you or your physician.
Are there any risks to me? 
We do not think there are any physical risks related to participating in this research study.
There are some potential side effects from taking the appetite stimulants. Please alert your 
doctor, Registered Dietitian, or research coordinator if you are experiencing any of these.
For dronabinol, >10% of the patients experience euphoria. Other not so common side 
effects can be: facial flushing, dizziness, abnormal thinking, drowsiness, paranoia, stomach 
pain, nausea, and vomiting.
For mirtazapine, >10% of the patients can experience drowsiness, dry mouth, or 
constipation. Other not so common side effects can be: swelling of the hands and feel, 
dizziness, abnormal dreams or thinking, skin rash, weakness, flu-like symptoms, and 
stomach pain. 
For dexamethasone, patients can have irritability, difficult sleeping, swelling in hands and 
feel, heartburn, muscle weakness, impaired wound healing, and increase blood sugar 
levels. Other not so common side effects can be dizziness, headaches, mood swings, and 
cataracts and bone thinning (with long term use). 
A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss 
of privacy means having your personal information shared with someone who is not on the 
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16
study team and was not supposed to see or know about your information. The study team 
plans to protect your privacy – see the Confidentiality section above for details.
Unknown Risks
We have described all the risks we know. However, because this is research, there a 
possibility that you will have a reaction that we do not know about yet and is not expected.
Are there possible benefits to me? 
You may or may not receive personal, direct benefit from taking part in this study. The 
possible benefits of taking part in this study include an improved quality of life and increased 
appetite. You will also receive frequent one-on-one nutrition counseling with a Registered 
Dietitian. 
What choices do I have other than participating in this study?
You can refuse to participate in the study. If you decide not to participate, the medical care 
providers at this facility will still give you all of the standard care and treatment that is 
appropriate for you.
Are there any consequences to me if I decide to stop participating in this study?
No. If you decide to take part, you are free to stop participating at any time without giving a 
reason. This will not affect your care and you will continue to be treated at this facility. 
However, some of the information may have already been entered into the study and that 
will not be removed. The researchers may continue to use and share the information they 
have already collected.
To revoke (take back) your consent and authorization, you must contact the Principal 
Investigator in writing at the address on page 1 of this form. However, you may first call or 
speak to the Principal Investigator and she will stop collecting new information about you.  If 
you take back your consent and authorization, you will not be allowed to continue to 
participate in this research study. 
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CONSENT TO PARTICIPATE
I have read the consent form and I understand that it is up to me whether or not I participate. I 
know enough about the purpose, methods, risks and benefits of the research study to decide 
that I want to take part in it. I understand that I am not waiving any of my legal rights by signing 
this informed consent document. I will be given a signed copy of this consent form.
Printed name of participant
Signature of participant
Date
Time
Printed name of the person 
conducting the consent 
process
Signature
Date
Time
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18
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Li, R. Wu, J. Ma, M. Pei, J. Song, Y. Zhang, X. Han, B. Comparison of PG-SGA, 
SGA, and body-composition measurement in detecting malnutrition among newly 
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IRB APPROVAL DATE: 02/10/2021


19
diagnosed lung cancer patients in stage IIIB/IV and benign conditions. Med Oncol. 
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Zhang, Liyan. Lu, Yuhan. Fang, Yu. Nutritional status and related factors of patients 
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outcome: a prospective randomized controlled trial in patients with head and neck cancer 
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Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves 
patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients 
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major benefit to colorectal cancer patients: long-term follow-up of a randomized controlled 
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10.3945/ajcn.111.018838.
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Cox S, Powell C, Carter B, Hurt C, Mukherjee S, Crosby TD. Role of nutritional 
status and intervention in oesophageal cancer treated with definitive chemoradiotherapy: 
outcomes from SCOPE1. Br J Cancer. 2016 Jul 12;115(2):172-7. doi: 
10.1038/bjc.2016.129.
24.
W Mattox, Todd. (2017). Cancer Cachexia: Cause, Diagnosis, and Treatment. 
Nutrition in clinical practice : official publication of the American Society for Parenteral 
and Enteral Nutrition. 32. 884533617722986. 10.1177/0884533617722986.
25.
Margaret-Mary G Wilson, David R Thomas, Laurence Z Rubenstein, John T 
Chibnall, Stephanie Anderson, Amy Baxi, Marilyn R Diebold, John E Morley; Appetite 
assessment: simple appetite questionnaire predicts weight loss in community-dwelling 
adults and nursing home residents, The American Journal of Clinical Nutrition, Volume 82, 
Issue 5, 1 November 2005, Pages 1074–1081, https://doi.org/10.1093/ajcn/82.5.1074
26.
Holm T, Maier A, Wicks P, et al. Severe Loss of Appetite in Amyotrophic Lateral 
Sclerosis Patients: Online Self-Assessment Study. Eysenbach G, ed. Interactive Journal of 
Medical Research. 2013;2(1):e8. doi:10.2196/ijmr.2463.
27.
Alan C. Tsai, Wei-Chung Hsu, Shu-Ching Chan & Tusi-Lan 
Chang (2011) Usefulness of the Mini Nutritional Assessment in Predicting the Nutritional 
Status of Patients With Liver Cancer in Taiwan, Nutrition and Cancer, 63:3, 334-
341, DOI: 10.1080/01635581.2011.535966
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20
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Álvarez-Camacho, M., Martínez-Michel, L., Gonella, S., Scrimger, R., Chu, K., & 
Wismer, W. (2016). Physical symptom burden of post-treatment head and neck cancer 
patients influences their characterization of food: Findings of a repertory grid 
study. European Journal of Oncology Nursing, 22, 54-62. doi:10.1016/j.ejon.2016.03.008
29.
Sim, B. Y., Lee, Y. W., Kim, H., & Kim, S. H. (2015). Post-traumatic growth in 
stomach cancer survivors: Prevalence, correlates and relationship with health-related 
quality of life. European Journal of Oncology Nursing, 19(3), 230-236. 
doi:10.1016/j.ejon.2014.10.017
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M. (2003). Evaluation of the Functional Assessment of Cancer Therapy-General (FACT-G) 
Spanish Version 4 in South America: Classic Psychometric and Item Response Theory 
Analyses. Health and Quality of Life Outcomes, 1(1), 32. doi:10.1186/1477-7525-1-32
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Doll, K., Snavely, A., Kalinowski, A., Irwin, D., Bensen, J., Bae-Jump, V., . . . 
Gehrig, P. (2014). Preoperative quality of life and surgical outcomes in gynecologic 
oncology patients: A new predictor of operative risk? Gynecologic Oncology, 133(3), 546-
551. doi:10.1016/j.ygyno.2014.04.002
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Swan, W. I., Vivanti, A., Hakel-Smith, N. A., Hotson, B., Orrevall, Y., Trostler, N., . 
. . Papoutsakis, C. (2017). Nutrition Care Process and Model Update: Toward Realizing 
People-Centered Care and Outcomes Management. Journal of the Academy of Nutrition 
and Dietetics,117(12), 2003-2014. doi:10.1016/j.jand.2017.07.015
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Moertel CG, Schutt AJ, Reitemeier RJ, Hahn RG. Corticosteroid therapy of 
preterminal gastrointestinal cancer. Cancer 1974; 33:1607.
36.
Kramer, J. L. (2014). Medical marijuana for cancer. CA: A Cancer Journal for 
Clinicians, 65(2), 109-122. doi:10.3322/caac.21260
37.
Haney M, Gunderson EW, Rabkin J, et al. Dronabinol and marijuana in HIV-positive 
marijuana smokers. Caloric intake, mood,and sleep. J Acquir Immune Defic Syndr. 
2007;45(5):545-554
38.
Beal JE, Olson R, Laubenstein L, et al. Dronabinol as a treatment for anorexia 
associated with weight loss in patients with AIDS. J Pain Symptom Manage. 
1995;10(2):89-97.
39.
Kim, S., Shin, I., Kim, J., Kim, Y., Kim, K., Kim, K., . . . Yoon, J. (2008). 
Effectiveness of mirtazapine for nausea and insomnia in cancer patients with 
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1819.2007.01778.x
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Kast RE, Foley KF: Cancer chemotherapy and cachexia: mirtazapine and olanzapine 
as 5-HT3 antagonists with good antinausea effects. Eur J Cancer Care (Engl). 2007, 
16(4):351–354
41.
Mantovani G, Madeddu C: Cyclooxygenase-2 inhibitors and antioxidants in the 
treatment of cachexia. Curr Opin Support Palliat Care 2008, 2(4):275–281. Review
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42.
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practice guideline for the management of major depressive disorder. 
https://www.healthquality.va.gov/guidelines/MH/mdd/VADoDMDDCPGFINAL82916.pdf
. Published April 2016.
43.
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Nutrition and Pharmacological Intervention for Oncology Patients With Anorexia
Eligibility Checklist
CONFIDENTIAL
The information contained in this document is regarded as confidential and, except to the extent 
necessary to obtain informed consent, may not be disclosed to another party unless law or 
regulations require such disclosure. Persons to whom the information is disclosed must be informed 
that the information is confidential and may not be further disclosed by them.
Inclusion Criteria
(list each criteria)
Yes
(all must be 
“yes” for 
eligibility)
No
1. Diagnosis of head/neck, lung, or pancreatic cancer or metastatic cancer of 
any primary solid malignancy
2. Planned, ongoing, or recently treated patient (within the past 30 days) with 
radiation therapy, chemotherapy, immunotherapy, and/or intravenous targeted 
biologic therapy
3. No previous use of appetite stimulants (steroid use for purposes other than 
appetite stimulant is allowed)
4. Signed study specific informed consent prior to being included in the study 
5. No contraindication to appetite stimulants
Participant is:
Eligible                    Not Eligible
Completed by:
________________________________
_____________
Print Name
Signature
Date
Investigator:             _________________________________
_____________
Print Name
Signature
Date
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Appendix 1
Patient Diagnosis:
Patient has been diagnosed with the following:
Height/Weight:
Weight: 
Symptoms
Problems eating: Yes/No
No appetite, just did not fell like eating (x1 week): Yes/No
Nausea/vomiting (x3 days): Yes/No
Constipation without BM (x>4 days): Yes/No
Mouth sores, oral mucositis: Yes/No
Problems or painful swallowing: Yes/No
Pain (specify where below): Yes/No
Diarrhea: Yes/No
Feel full quickly: Yes/No
Fatigue: Yes/No
Ostomy: Yes/No
Open wound or ulcer: Yes/No
Visible cachexia/muscle wasting: Yes/No
Trouble buying food: Yes/No
Assessment Completed (Auto-Calculation): 
Referral to Nutritionist
Referral:
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Appendix 2
Council on Nutrition Appetite Questionnaire 
1) My appetite is 
1. Very poor
2. Poor
3. Average 
4. Good 
5. Very good 
2) When I eat, I feel full after 
1. Eating only a few mouthfuls 
2. Eating about a third of a plate/meal 
3. Eating over half of a plate/meal 
4. Eating most of the food
5. Hardly ever 
3) I feel hungry 
1. Never 
2. Occasionally 
3. Some of the time
4. Most of the time
5. All of the time 
4) Food tastes 
1. Very bad 
2. Bad 
3. Average 
4. Good 
5. Very good 
5)  Compared to when I was younger, food tastes 
1. Much worse
2. Worse 
3. Just as good
4. Better 
5. Much better 
6)  Normally, I eat 
1. Less than one regular meal a day
2. One meal a day 
3. Two meals a day 
4. Three meals a day 
5. More than three meals a day (including snacks) 
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7)  I feel sick or nauseated when I eat 
1.  Most times 
2.  Often 
3.  Sometimes
4.  Rarely 
5.  Never 
8)  Most of the time my mood is 
1.  Very sad 
2.  Sad 
3.  Neither sad nor happy 
4.  Happy 
5.  Very happy 
TOTAL SCORE: ______________
Scoring Total the score by adding the numbers associated with the patient’s response. A 
score of less than 28 is cause for concern. If the total is 8-16, the patient is at risk for anorexia 
and needs nutrition counseling. 17-28, the patient needs frequent reassessment. >28, the 
patient is not at risk at this time.
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Appendix 3:
FACT-GP (Version 4)
Below is a list of statements that other people have said are important. Please circle or mark 
one number per line to indicate your response as it applies to the past 7 days.
PHYSICAL WELL-BEING
Not 
at all
A 
little 
bit
Some
-what
Quite
a bit
Very 
much
G
P
1
I have a lack of energy
............................................................................
0
1
2
3
4
G
P
2
I have nausea
............................................................................
0
1
2
3
4
G
P
3
Because of my physical condition, I have 
trouble meeting the needs of my family
............................................................................
0
1
2
3
4
G
P
4
I have pain
............................................................................
0
1
2
3
4
G
P
6
I feel ill
............................................................................
0
1
2
3
4
G
P
7
I am forced to spend time in bed
............................................................................
0
1
2
3
4
SOCIAL/FAMILY WELL-BEING
Not 
at all
A 
little 
bit
Some
-what
Quite
a bit
Very 
much
G
S
1
I feel close to my friends
............................................................................
0
1
2
3
4
G
S
2
I get emotional support from my family
............................................................................
0
1
2
3
4
G
S
3
I get support from my friends
............................................................................
0
1
2
3
4
G
S
6
I feel close to my partner (or the person who 
is my main support)
............................................................................
0
1
2
3
4
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Q
1
Regardless of your current level of sexual activity, please answer the following 
question. If you prefer not to answer it, please mark this box           and go to the 
next section.
G
S
7
I am satisfied with my sex life
............................................................................
0
1
2
3
4
EMOTIONAL WELL-BEING
Not 
at all
A 
little 
bit
Some
-what
Quite
a bit
Very 
much
G
E
1
I feel sad
..............................................................................
0
1
2
3
4
G
E
4
I feel nervous
..............................................................................
0
1
2
3
4
G
E
5
I worry about dying
..............................................................................
0
1
2
3
4
G
E
I worry that my condition will get worse
..............................................................................
0
1
2
3
4
FUNCTIONAL WELL-BEING
Not 
at all
A 
little 
bit
Some
-what
Quite
a bit
Very 
much
G
F
1
I am able to work (include work at home)
.............................................................................
0
1
2
3
4
G
F
2
My work (include work at home) is fulfilling
.............................................................................
0
1
2
3
4
G
F
3
I am able to enjoy life
.............................................................................
0
1
2
3
4
G
F
5
I am sleeping well
.............................................................................
0
1
2
3
4
G
F
6
I am enjoying the things I usually do for fun
.............................................................................
0
1
2
3
4
G
F
I am content with the quality of my life right 
now
0
1
2
3
4
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Appendix 4
IRB NUMBER: 2019-10218
IRB APPROVAL DATE: 02/10/2021