Clinical trial · Interventional
A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss
AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss
NCT00094562CI-TRIAL-00036619completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cancer Cachexia | — | UNRESOLVED | — |
| Chronic Heart Failure | — | UNRESOLVED | — |
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fish oil supplement | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Body weight
- measure
- lean body mass
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.