A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

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.