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RATIONALE: Cyproheptadine may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying cyproheptadine to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
- To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.
- To assess the pattern of weight change between two groups during the study.
- To investigate the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition between two groups (treatment vs placebo) at completion of therapy compared to baseline measures.
- To investigate the effect of cyproheptadine hydrochloride on each biomarker (prealbumin and transferrin) of malnourishment and on body composition within the treatment group at completion of therapy compared to baseline measures, specifically those patients with no weight loss as compared to those patients who experience weight loss.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and steroid use with cancer treatment (yes vs no). Patients begin study treatment before the first dose of chemotherapy.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 16 weeks.
- Arm II: Patients receive an oral placebo twice daily for 16 weeks. Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4, 8, 12, and 16 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4, 8, 12, and 16 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.
Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin and transferrin levels.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
cyproheptadine hydrochloride, placebo
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:13:21-0400
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