Status:
COMPLETED
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Cancer
Cancer Cachexia
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00094562
Start Date
June 1 2004
End Date
September 1 2007
Last Update
January 18 2019
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287