NCT02681601

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

July 19, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

August 3, 2022

Status Verified

October 1, 2021

Enrollment Period

5.2 years

First QC Date

January 27, 2016

Last Update Submit

August 1, 2022

Conditions

Cancer of Pancreas

Keywords

Diet, Food, and Nutrition

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • Blood biochemistry

    At each visit outlined for 3 months

  • Blood biochemistry

    At each visit outlined for 3 months

  • Blood biochemistry

    At each visit outlined for 3 months

  • Blood biochemistry

    At each visit outlined for 3 months

  • Blood biochemistry

    At each visit outlined for 3 months

  • +6 more secondary outcomes

Study Arms (2)

Diet + Nutrawell Powder with Fish Oil

ACTIVE COMPARATOR

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 PowderDietary Supplement: OmegaRich fish oil supplement

Dietary Intervention Only

ACTIVE COMPARATOR

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

Interventions

Nutrawell PowderDIETARY_SUPPLEMENT

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 + Nutrawell Powder with Fish Oil
Diet OnlyOTHER

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

Dietary Intervention Only
OmegaRich fish oil supplementDIETARY_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.

Diet + Nutrawell Powder with Fish Oil

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Department of Medicine Center for Human Nutrition

Los Angeles, California, 90095, United States

Location

Related Publications (10)

  • Lillemoe KD. Palliative therapy for pancreatic cancer. Surg Oncol Clin N Am. 1998 Jan;7(1):199-216.

    PMID: 9443996BACKGROUND

  • 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.

    PMID: 16214989BACKGROUND

  • 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.

    PMID: 16048664BACKGROUND

  • 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.

    PMID: 12970142BACKGROUND

  • 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.

    PMID: 22212388BACKGROUND

  • 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.

    PMID: 8233390BACKGROUND

  • 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.

    PMID: 22824168BACKGROUND

  • 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.

    PMID: 21760776BACKGROUND

  • 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.

    PMID: 26487965BACKGROUND

  • 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.

    PMID: 8648360BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Zhaoping Li, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 12, 2016

Study Start

July 19, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

August 3, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)