Cancer Clinical Trial
Official title:
AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss
Verified date | April 2008 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | |||
Primary | lean body mass |
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