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A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
This study has been completed.
Study NCT00094562   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: October 20, 2004   Last Updated: April 21, 2008   History of Changes

October 20, 2004
April 21, 2008
June 2004
September 2007   (final data collection date for primary outcome measure)
  • Body weight
  • lean body mass
Same as current
Complete list of historical versions of study NCT00094562 on ClinicalTrials.gov Archive Site
 
 
 
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss

The purpose of this study is to evaluate the safety and effectiveness of fish oil supplements in maintaining weight in people with disease-related weight loss and/or cachexia.

The overall goal of this project is to evaluate the safety and efficacy of nutritional supplementation with fish oils to maintain weight in patients with disease-related weight loss (cachexia). Weight loss commonly results in a poorer prognosis, functional status, and quality of life. Despite the high morbidity and mortality associated with cachexia, mainstream treatment does not sustain weight and although nutritional supplements are commonly used, many of these have not been tested in clinical trials. Recent work in cachexia has revealed that this is mediated by pro-inflammatory cytokines. There are data that suggests that fish oils can affect the underlying pathogenic inflammatory response and have an affect on weight maintenance and nutritional balance

Diseases in which cachexia is most common:

  • Cancer
  • Chronic Heart Failure (CHF)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Rheumatoid Arthritis (RA)

Goals of the Study:

  • To evaluate the safety and efficacy of fish oils vs. corn oil in the maintenance of weight and lean body mass in patients with disease-related weight loss.
  • To understand the mechanism of fish oil effect on health maintenance by evaluating the anti-inflammatory, anti-catabolic, anti-oxidant and anabolic actions of these compounds
  • To document the effect of our interventions on quality of life and functional status.

Study Outline:

Participants will be randomly assigned to receive either fish oil supplements or corn oil for the duration of this 3-month study. Participants will have five study visits and two telephone interviews. During each study visit, participants will undergo laboratory tests, a physical exam, and a dual energy X-ray absorptiometry (DEXA) bone scan. Participants will be asked to keep a food diary during the study. During the telephone interviews, participants will be asked health-related questions and discuss their current functional status.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Cancer
  • Cancer Cachexia
  • Chronic Obstructive Pulmonary Disease
  • Chronic Heart Failure
  • Rheumatoid Arthritis
Drug: Fish oil supplement
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and Women with disease-related weight loss e.g. cardiac cachexia, COPD, CHF, RA.
  • All stages of Pancreatic cancer patients (No weight loss requirements)
  • All stages of cancer with 5% weight loss
  • At least 6 weeks post-surgery
  • On a stable dose of medications for at least 6 weeks prior to study entry
  • Most recent ECOG Performance status score of 0,1,2,or 3 if applicable
  • Agree to use acceptable methods of contraception during the study and for 3 months after study completion, for female participants. Females with reproductive potential must have a negative urine or serum pregnancy test within 7 days of study.
  • Willing to continue current therapy for cancer for the duration of the study
  • If with diabetes mellitus HgbA1C of <10%
  • Adequate bone marrow function ANC> 1000/mm3, platelets 50,000/mm3, hemoglobin, 8g/dl.
  • No active infections including known history of HIV or viral hepatitis.

Exclusion Criteria:

  • Esophageal Cancer
  • Individuals with hypertriglyceridemia
  • Life expectancy of less than 12 weeks
  • Alcohol consumption more than 3 drinks/day for men or 2 drinks/day for women.
  • Untreated endocrine problems
  • Severe Depression
  • Untreated endocrine problems, such as hypothyroidism. Gonadal dysfunction from a known primary endocrine dysfunction (e.g. Klinefelters syndrome, pituitary tumor, testicular neoplasms, testicular surgery.
  • Medications that impair sex hormone synthesis, secretion, or function (e.g. spironolactone, anti-estrogens, anabolic steroids and androgens.
  • Fish oils within 3 months prior to study entry.
  • Any infectious disease, such as HIV or viral hepatitis.
  • Vitamins in doses greater than the Recommended Daily Allowance (RDA)
  • Herbs in the month prior to study entry.
  • Only participation in other cachexia studies is prohibited.
  • Prothrombin Time INR > 2.5 on Coumadin and INR > 2.0 not on Coumadin.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00094562
 
P50 AT000437, JHM - IRB # 03-02-10-12
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Adrian S. Dobs, MD, MHS Johns Hopkins University
National Center for Complementary and Alternative Medicine (NCCAM)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP