Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01200602|
Recruitment Status : Terminated (The study closed due to slow accrual.)
First Posted : September 13, 2010
Results First Posted : May 24, 2013
Last Update Posted : November 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Weight Changes||Drug: megestrol acetate Other: clinical observation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||January 2012|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200602
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Vilmarie Rodriguez, M.D.||Mayo Clinic|