A randomized, double-blind, placebo-controlled clinical trial of megestrol acetate as an appetite stimulant in children with weight loss due to cancer and/or cancer therapy

A randomized, double-blind, placebo-controlled clinical trial of megestrol acetate as an appetite stimulant in children with weight loss due to cancer and/or cancer therapy

Background Megestrol acetate (MA) is an appetite stimulant with efficacy in promoting weight gain in adults with cancer‐associated anorexia–cachexia. Studies documenting MA efficacy in children, however, are limited. We present the first randomized, double‐blind, placebo‐controlled clinical trial of...

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Published in:Pediatric blood & cancer Vol. 61; no. 4; pp. 672 - 679
Main Authors: Cuvelier, Geoff D.E., Baker, Tina J., Peddie, Elaine F., Casey, Linda M., Lambert, Pascal J., Distefano, Dianne S., Wardle, Marlene G., Mychajlunow, Beth A., Romanick, Marcel A., Dix, David B., Wilson, Beverly A.
Format: Journal Article
Language:English
Published: United States Blackwell Publishing Ltd 01-04-2014
Wiley Subscription Services, Inc
Subjects:
Adolescent
Adult
Appetite - drug effects
appetite stimulant
Appetite Stimulants - therapeutic use
Child
Child, Preschool
Double-Blind Method
Female
Follow-Up Studies
Hematology
Humans
Infant
Male
megestrol acetate
Megestrol Acetate - therapeutic use
Neoplasm Staging
Neoplasms - complications
Neoplasms - therapy
Nutrition Disorders - diagnosis
Nutrition Disorders - drug therapy
Nutrition Disorders - etiology
Oncology
pediatric cancer
Pediatrics
Prognosis
Quality of Life
randomized trial
weight loss
Weight Loss - drug effects
Young Adult
megestrol acetate
weight loss
appetite stimulant
randomized trial
pediatric cancer
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Summary:Background Megestrol acetate (MA) is an appetite stimulant with efficacy in promoting weight gain in adults with cancer‐associated anorexia–cachexia. Studies documenting MA efficacy in children, however, are limited. We present the first randomized, double‐blind, placebo‐controlled clinical trial of MA versus placebo in children with cancer and weight loss. Methods Subjects <18 years of age with weight loss (minimum 5% from highest previous weight; or %ideal body weight <90%) due to cancer and/or cancer therapy were randomized to either MA (7.5 mg/kg/day) or placebo for a planned study duration of 90 days. Primary outcome was the difference between groups in mean percent weight change from beginning to end of the study period. Secondary outcomes included effects on anthropometrics, body composition, need for tube feeding or parenteral nutrition, and toxicities. Results Twenty‐six patients were randomly assigned (13 MA, 13 placebo). The MA group experienced a mean weight gain of +19.7% compared to a mean weight loss of −1.2% in the placebo group, for a difference of +20.9% (95%CI: +11.3% to +30.5%, P = 0.003) in favor of MA over placebo. MA subjects experienced significant increases in weight for age z‐scores, body mass index z‐scores, and mid upper arm circumference compared to placebo. DXA scanning suggested disproportionate increases in fat accrual. Adrenal suppression was the main toxicity of MA. Conclusion In children with high‐risk malignancies, MA resulted in significant increases in mean percent weight change compared to placebo. Further studies of MA should be pursued to better delineate the effect on nutritional status. Pediatr Blood Cancer 2014;61:672–679. © 2013 Wiley Periodicals, Inc.
Bibliography:istex:AFD6549AFAB20015D2445103533A1381CF0DC863
May McLeod Northern Alberta Childhood Cancer Research Fund
UBC Division of Pediatric Hematology-Oncology-BMT Research Fund
ArticleID:PBC24828
ark:/67375/WNG-R3SB592W-0
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:1545-5009
1545-5017
DOI:10.1002/pbc.24828