A Fish Oil Supplement 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.
Checked against the public recordLast updated Jan 18, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Interventions being studied
- Drug: Fish oil supplement
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Johns Hopkins HospitalBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 18, 2019. Always confirm current availability with the study team.