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Megestrol Acetate vs EPA Enriched Nutritional Supplement vs Both for Cancer Cachexia and Anorexia
NCT00031707Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2000
- Primary completion
- Jan 2004
- Countries
- 2
- Sponsor
- Cancer and Leukemia Group B
- Modality
- Small Molecules
- Conditions
- cancer cachexiaanorexia nervosa (AN)
01
Overview
Phase 3, randomised, double-blind trial in cancer cachexia and anorexia nervosa (AN) comparing megestrol + placebo, eicosapentaenoic acid + placebo and megestrol + eicosapentaenoic acid (3 arms). Primary endpoints: Patient Weight up to 5 years, Rate of Weight Change up to 5 years and 1 more. Started Mar 2000; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
megestrol + placebo
Oral megestrol once daily and oral placebo twice daily.
eicosapentaenoic acid + placebo
Oral placebo once daily and EPA-enriched nutritional supplement twice daily.
megestrol + eicosapentaenoic acid
Oral megestrol once daily and EPA-enriched nutritional supplement twice daily.
03
Who it enrols
Adults with incurable cancer (excluding brain, breast, ovarian, endometrial, or prostate) experiencing at least 5 pounds of weight loss in the past 2 months or caloric intake < 20 cal/kg daily, with an ECOG PS of 0-2 and life expectancy of at least 3 months.
04
Endpoints
Primary
Patient Weight
Rate of Weight Change
Appetite
Secondary
Quality of Life
Overall Survival
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