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.
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): 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|