A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia
PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.
SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity
Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral
megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily)
daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4
weeks. After completion of study treatment, patients are followed up for 12 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Proportion of Patients Who Maintain Weight or Experience Weight Gain
A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
Vilmarie Rodriguez, M.D.
United States: Food and Drug Administration
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