NCT00066248

Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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 cyproheptadine 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.

Conditions

• Brain Tumor
• Central Nervous System Tumors
• Cachexia
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	cyproheptadine hydrochloride	Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
DRUG	megestrol acetate	Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2003-08-07
• Last updated: 2014-02-03

Locations

43 sites across 3 countries: United States, Canada, Puerto Rico