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

Phase 2

Completed

• Conditions: Brain Tumor; Central Nervous System Tumors; Myelodysplastic Syndromes; Unspecified Childhood Solid Tumor, Protocol Specific; Myelodysplastic/Myeloproliferative Diseases; Cachexia; Leukemia; Lymphoma
• Interventions: Drug: cyproheptadine hydrochloride; Drug: megestrol acetate

• Registration Number: NCT00066248
• Lead Sponsor: University of South Florida

Brief 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects that respond to Periactin	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.
Non-responders to Periactin- Megace Arm	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.
Non-responders to Periactin- Megace Arm	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment	4-8 weeks

Secondary Outcome Measures

Name	Time	Method
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	4-8 weeks

Trial Locations

Locations (43)

CCOP - Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Children's Hospital & Research Center Oakland; 🇺🇸 Oakland, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida Shands Cancer Center; 🇺🇸 Gainesville, Florida, United States

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital; 🇺🇸 Pensacola, Florida, United States

All Children's Hospital; 🇺🇸 St. Petersburg, Florida, United States

St. Joseph's Children's Hospital of Tampa; 🇺🇸 Tampa, Florida, United States

CCOP - Florida Pediatric; 🇺🇸 Tampa, Florida, United States

Kaplan Cancer Center at St. Mary's Medical Center; 🇺🇸 West Palm Beach, Florida, United States

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