A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer
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|ClinicalTrials.gov Identifier: NCT00439101|
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : July 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Malnourished Children With Cancer||Drug: Megstrol Acetate Other: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double Blind, Placebo-Controlled Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With Cancer|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Drug: Megstrol Acetate
Megestrol acetatet 7.5 mg/kg/day orally (lemon-lime suspension) for 90 days.
Placebo Comparator: 2
Placebo (lemon-lime suspension) taken orally for 90 days.
- To determine if daily administration of megestrol acetate (MA) for 3 months compared to placebo prevents weight loss or improves weight gain in children with cancer-associated anorexia-cachexia.
- • To investigate whether MA results in improvement in other anthropometric measures of nutritional status (e.g. weight-for-height, triceps skinfolds, mid upper-arm circumference).
- To investigate whether MA has a beneficial effect on body composition using dual-energy x-ray absorptiometry (DXA).
- To determine if appetite stimulation following MA therapy results in improved quality of life for children with cancer-associated cachexia.
- To determine if MA results in fewer requirements for invasive nutritional support such as tube feeding, gastrostomy tubes, and TPN.
- To evaluate toxicities associated with MA in pediatric oncology subjects.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439101
|Canada, British Columbia|
|Stollery Children's Hospital|
|Edmonton, British Columbia, Canada, T6G 2B7|
|Children's & Women's Health Centre of British Columbia|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||David Dix, MD||University of British Columbia|
|Principal Investigator:||Beverly Wilson, MD||University of Alberta|