Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia

Date de début de l'étude : 1 octobre 1995

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