Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
|Anorexia Weight Changes||Drug: megestrol acetate Other: clinical observation||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia|
- Proportion of Patients Who Maintain Weight or Experience Weight Gain [ Time Frame: 4 weeks ]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.
- BMI Trends [ Time Frame: 4 weeks ]
- Caloric Intake [ Time Frame: 4 weeks ]
- Weight Maintenance Over Time [ Time Frame: 4 weeks ]
- Toxicity Profile [ Time Frame: 4 weeks ]Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0
|Study Start Date:||March 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
Drug: megestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
Active Comparator: Arm B
Patients have clinical observation for weight loss and gain for 4 weeks.
Other: clinical observation
No treatment is given.
Other Name: observation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200602
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Vilmarie Rodriguez, M.D.||Mayo Clinic|