NCT00031707

Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite

Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.

Detailed description

OBJECTIVES: * Compare the appetite-stimulating properties of megestrol vs an eicosapentaenoic acid-enriched nutritional supplement vs both, in terms of patient weight, rate of weight change, and appetite, in patients with cancer-related cachexia and anorexia. * Determine the effect of these regimens on nausea and vomiting in these patients. * Assess quality of life in patients treated with these regimens. * Determine the toxic effects of these regimens in these patients. * Compare overall survival of patients treated with these regimens. * Correlate interleukin-6 concentration changes with appetite and weight changes in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary cancer (lung vs gastrointestinal vs other), severity of weight loss in the past 2 months (less than 10 pounds vs 10 pounds or more), planned concurrent chemotherapy (yes vs no), age (under 50 vs 50 and over), and prognosis (good vs bad vs unsure). Patients are randomized to 1 of 3 treatment arms.

Conditions

• Anorexia
• Cachexia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	eicosapentaenoic acid
DRUG	megestrol acetate
OTHER	placebo

Timeline

• Start date: 2000-03-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2003-08-05
• Last updated: 2016-07-14

Locations

44 sites across 2 countries: United States, Canada