Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
NCT ID: NCT02681601
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2016-07-19
2021-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Diet Only
Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)
Interventions
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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.
Diet Only
Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
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Do Well Laboratories Inc.
UNKNOWN
Hirshberg Foundation for Pancreatic Cancer Research
UNKNOWN
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Zhaoping Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Department of Medicine Center for Human Nutrition
Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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15-001926
Identifier Type: -
Identifier Source: org_study_id
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