Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer patients with cachexia. Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients (phase I completed 12/1999). Determine whether omega-3 fatty acids will result in an antitumor response. OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by the extent of weight loss (2-5 percent or greater than 5 percent in the past month). 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. The maximum tolerated dose (MTD) is defined as the highest dose level at which no greater than one-third of the patients treated, including escalated patients from a lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).

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

Conditions
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Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Dietary Supplement: omega-3 fatty acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 fatty acid<br>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. | Dietary Supplement: omega-3 fatty acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | up to 4 months |