Conditions: Anorexia Weight Changes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief summary:
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.

Detailed description:
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.

Arms:
arm 1: Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. arm 2: Patients have clinical observation for weight loss and gain for 4 weeks.

Interventions: intervention 1: megestrol acetate intervention 2: clinical observation
Intervention descriptions: intervention 1: Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day intervention 2: No treatment is given.

Protocol document: