Clinical trial · Interventional
Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
NCT00003077CI-TRIAL-00022982completedPhase 1 / Phase 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)
RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may be an effective treatment for patients with advanced cancer who are unable to maintain their body weight. PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omega-3 fatty acid
- description
- Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and lunch for 4 months or until weight loss is observed. Dose is escalated in cohorts of two patients, although dose escalation is allowed in individual patients. Patients are evaluated for cachexia response every 2 weeks, and tumor response every 4 weeks for a maximum of 4 months. If no response of cachexia or tumor after a 2 month period, patients will be discontinued from study. Patients will be followed for survival post-treatment.
- interventionNames
- Dietary Supplement: omega-3 fatty acid
Primary outcomes (1)
- measure
- survival
- timeFrame
- up to 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven advanced cancer not amenable to curative therapy (solid tumors and hematologic malignancies eligible except primary and metastatic brain tumors) * Cachexia (weight loss at least 2 percent within a one month period) PATIENT CHARACTERISTICS: Age: * 18 and over Performance Status: * CALBG 0-2 Life Expectancy: * At least 2 months Hematopoietic: * Granulocytes greater than 1,000/mm3 * Platelet count greater than 75,000/mm3 * Hemoglobin greater than 8 mg/dL Hepatic: * AST less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN * Bilirubin less than 1.5 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Cardiovascular: * No congestive heart failure requiring diuretics within less than 6 months * No uncontrolled or severe cardiovascular disease within less than 6 months * No myocardial infarction within less than 6 months Other: * Not pregnant nor contemplating pregnancy during study * Negative pregnancy test * No uncontrolled hypercalcemia * No metabolic disorders (hyperthyroidism) * No poorly controlled diabetes * No peripheral edema or ascites requiring diuretics * No enteric fistulas, with tracheobronchial fistulas or with aspiration * No esophageal or bowel obstruction that would preclude eating * Free T4 within normal range * No serious medical illness * No psychosis * No uncontrolled bacterial, viral, or fungal infections * No active uncontrolled duodenal ulcers * Above laboratory values required unless bone marrow, liver, kidney, or splenic involvement by tumor is documented PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior and concurrent chemotherapy allowed Endocrine therapy: * No concurrent steroids such as dronabinol or megestrol acetate (except for adrenal failure) Radiotherapy: * No prior or concurrent radiotherapy to abdomen or pelvis Surgery: * Greater than 3 weeks since major surgery * Greater than 1 week since minor surgery Other: * No concurrent diuretics
References
Publications (1)
- RESULTBurns CP, Halabi S, Clamon G, Kaplan E, Hohl RJ, Atkins JN, Schwartz MA, Wagner BA, Paskett E. Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia. Cancer. 2004 Jul 15;101(2):370-8. doi: 10.1002/cncr.20362. PMID 15241836