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

Completed · Phase 2

Conditions studied: Cancer, Cancer Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure, Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00094562

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

25

Starts

2004-06-01

Expected to finish

2007-09-01

Last updated by the study team

2019-01-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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