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.

Study Overview

• Status: Terminated
• Conditions: Cancer of Pancreas
• Intervention / Treatment: Dietary supplement: Nutrawell Powder; Dietary supplement: OmegaRich fish oil supplement; Other: Diet Only

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Department of Medicine Center for Human Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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 Center for Human Nutrition research unit. OmegaRich Contains high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish. Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA.; 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 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish. Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Do Well Laboratories Inc.; Hirshberg Foundation for Pancreatic Cancer Research

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2016
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (ESTIMATE): February 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diet, Food, and Nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 15-001926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO