Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.
PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.
Brain and Central Nervous System Tumors
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: cyproheptadine hydrochloride
Drug: megestrol acetate
|Study Design:||Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia|
- Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
- Effect of study agents on protein and fat levels as measured by pre-albumin and lipid profile at baseline, and 4 weeks after the beginning of study treatment
|Study Start Date:||June 2003|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia.
- Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine.
- Determine how these drugs affect body protein and fat levels in these patients.
OUTLINE: Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients responding to either cyprohepatadine or megestrol may continue treatment at the discretion of the treating physician.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Show 43 Study Locations
|Study Chair:||Jennifer L. Mayer, MD||H. Lee Moffitt Cancer Center and Research Institute|