Nutrition Support To Improve Outcomes In Patients With Unresectable Pancreatic Cancer

Study Overview

Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

There are few well-designed studies evaluating the effect of nutrition support in patients with cancer cachexia. The aim of this study is to examine the effect of dietary prescription with and without nutrition supplementation in patients with unresectable pancreatic cancer on body weight, body composition, total calorie intake, quality of life and blood inflammatory markers.

A total of 60 subjects will be recruited from The University of California Los Angeles (UCLA) Hirshberg Pancreatic Cancer Center, print and/or radio advertisements, UCLA campus wide e-mail, and flyers posted on campus and in the community. Participants will be pre-screened over the telephone to determine eligibility. Eligible subjects will be asked to come to the Center for Human Nutrition for a Screening Visit. At screening, informed consent and authorization will be reviewed and signed a medical history will be obtained. The subjects will be screened by medical history/physical exam, a fasting blood sample will be collected for a comprehensive metabolic panel, a complete blood count, chemistry and liver function tests. Day 1 will be the first study day. Subjects will come to the UCLA Center for Human Nutrition in the fasting state and remain for approximately ~1 hour. The food intake record will be collected and entered into the Automated Self- Administered Food Recall (NIH ASA24). The vital signs, anthropometric assessments will be measured and quality of life questionnaire will be completed. A fasting blood sample (20 ml) will be collected for metabolic panel and inflammatory markers. A 6-minute walk will be done at the research center. Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein) vs. the same diet prescription including three servings of supplement powder and fish oil. The research dietitian will develop meal plans based on basal metabolic rate and physical activity. Subjects will be provided a pedometer to wear daily. Any subject in either group who develops symptoms of pancreatic insufficiency will be provided with pancreatic enzyme supplementation. Day 28, 56, 84 and 112 will be follow-up visits. The same procedures will be performed as on day 1. Subjects will come to the UCLA Center for Human Nutrition in the fasting state and remain for approximately ~1 hour.

Cancer of Pancreas

DIETARY_SUPPLEMENT: Nutrawell Powder
OTHER: Diet Only
DIETARY_SUPPLEMENT: OmegaRich fish oil supplement

15-001926

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-01-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-08-01
First Submitted that Met QC Criteria 2016-02-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-08-03
First Posted (ACTUAL) 2016-02-12	Results First Posted N/A	Last Verified 2021-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Diet + Nutrawell Powder with Fish Oil Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) including Nutrawell powder with fish oil.	DIETARY_SUPPLEMENT: Nutrawell Powder The NutraWell nutrition powder will be provided by and distributed from New Health Nutraceuticals (Irvine, California - USA). Nutrawell is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Cente DIETARY_SUPPLEMENT: OmegaRich fish oil supplement OmegaRich is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit. OmegaRich Contains: high concentration and high purity of natural omega-3 polyunsaturate
ACTIVE_COMPARATOR: Dietary Intervention Only Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) not including servings of Nutrawell powder with fish oil.	OTHER: Diet Only Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Diet + Nutrawell Powder with Fish Oil

Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) including Nutrawell powder with fish oil.

DIETARY_SUPPLEMENT: Nutrawell Powder

The NutraWell nutrition powder will be provided by and distributed from New Health Nutraceuticals (Irvine, California - USA). Nutrawell is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Cente

DIETARY_SUPPLEMENT: OmegaRich fish oil supplement

OmegaRich is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit. OmegaRich Contains: high concentration and high purity of natural omega-3 polyunsaturate

ACTIVE_COMPARATOR: Dietary Intervention Only

Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) not including servings of Nutrawell powder with fish oil.

OTHER: Diet Only

Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)

Primary Outcome Measures	Measure Description	Time Frame
Anthropometric measurement: Weight	Weight in Kilograms	At each visit outlined for 3 months
Anthropometric measurement: Body Composition	Body Composition: kilogram weight of lean body mass	At each visit outlined for 3 months

Secondary Outcome Measures	Measure Description	Time Frame
Blood biochemistry	complete blood count	At each visit outlined for 3 months
Blood biochemistry	Blood electrolytes	At each visit outlined for 3 months
Blood biochemistry	Liver function test	At each visit outlined for 3 months
Blood biochemistry	Lipid panel	At each visit outlined for 3 months
Blood biochemistry	Pancreatic tumor markers	At each visit outlined for 3 months
Blood biochemistry	Inflammatory markers	At each visit outlined for 3 months
Physical activity	All subjects will be provided a pedometer to record daily steps.	At each visit outlined for 3 months
Physical activity	A 6 minute walk will be done at each visit.	At each visit outlined for 3 months
Physical activity	Karnofsky performance score	At each visit outlined for 3 months
Quality of life: General	Measured with short form health survey (SF36)	At each visit outlined for 3 months
Quality of life: Appetite	Appetite will be measured on a numerical rating scale between 0 and 10, where 0 indicated absolutely no appetite and 10 indicated an extremely good appetite (Simons et al, 1996)	At each visit outlined for 3 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
MALE

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Unresectable pancreatic adenocarcinoma
Weight loss of greater than 5% in the previous 6 months
Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more.
Non-smokers

Chemotherapy other than gemcitabine
Radiotherapy, or surgical treatment in the previous month
Consumption of dietary supplements or medications such as steroids that could affect metabolism.
Presence of ascites
Liver function test > 2 standard deviation of upper limit
Chronic or acute renal insufficiency
Severe anemia with hemoglobin<10
Uncontrolled pain
Uncontrolled nausea and vomiting
Participation in a therapeutic research study within 30 days of baseline
Diet restrictions including vegetarianism and veganism
Allergy or intolerance to fish and/or fish oil

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Do Well Laboratories Inc.
Hirshberg Foundation for Pancreatic Cancer Research

Investigators

PRINCIPAL_INVESTIGATOR: Zhaoping Li, MD, PhD, University of California, Los Angeles

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lillemoe KD. Palliative therapy for pancreatic cancer. Surg Oncol Clin N Am. 1998 Jan;7(1):199-216.
Capra S, Bauer J, Davidson W, Ash S. Nutritional therapy for cancer-induced weight loss. Nutr Clin Pract. 2002 Aug;17(4):210-3. doi: 10.1177/0115426502017004210.
Stratton RJ. Should food or supplements be used in the community for the treatment of disease-related malnutrition? Proc Nutr Soc. 2005 Aug;64(3):325-33. doi: 10.1079/pns2005439.
Fearon KC, Von Meyenfeldt MF, Moses AG, Van Geenen R, Roy A, Gouma DJ, Giacosa A, Van Gossum A, Bauer J, Barber MD, Aaronson NK, Voss AC, Tisdale MJ. Effect of a protein and energy dense N-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: a randomised double blind trial. Gut. 2003 Oct;52(10):1479-86. doi: 10.1136/gut.52.10.1479.
Cawood AL, Elia M, Stratton RJ. Systematic review and meta-analysis of the effects of high protein oral nutritional supplements. Ageing Res Rev. 2012 Apr;11(2):278-96. doi: 10.1016/j.arr.2011.12.008. Epub 2011 Dec 22.
Goldberg MF, Custis PH. Retinal and other manifestations of incontinentia pigmenti (Bloch-Sulzberger syndrome). Ophthalmology. 1993 Nov;100(11):1645-54. doi: 10.1016/s0161-6420(93)31422-3.
Kraft M, Kraft K, Gartner S, Mayerle J, Simon P, Weber E, Schutte K, Stieler J, Koula-Jenik H, Holzhauer P, Grober U, Engel G, Muller C, Feng YS, Aghdassi A, Nitsche C, Malfertheiner P, Patrzyk M, Kohlmann T, Lerch MM. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN)--a randomized multicentre trial. Nutr J. 2012 Jul 23;11:52. doi: 10.1186/1475-2891-11-52.
Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. Epub 2011 Jun 13.
Kleponis J, Skelton R, Zheng L. Fueling the engine and releasing the break: combinational therapy of cancer vaccines and immune checkpoint inhibitors. Cancer Biol Med. 2015 Sep;12(3):201-8. doi: 10.7497/j.issn.2095-3941.2015.0046.
Simons JP, Aaronson NK, Vansteenkiste JF, ten Velde GP, Muller MJ, Drenth BM, Erdkamp FL, Cobben EG, Schoon EJ, Smeets JB, Schouten HC, Demedts M, Hillen HF, Blijham GH, Wouters EF. Effects of medroxyprogesterone acetate on appetite, weight, and quality of life in advanced-stage non-hormone-sensitive cancer: a placebo-controlled multicenter study. J Clin Oncol. 1996 Apr;14(4):1077-84. doi: 10.1200/JCO.1996.14.4.1077.

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