Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
- Conditions
- Brain TumorCentral Nervous System TumorsMyelodysplastic SyndromesUnspecified Childhood Solid Tumor, Protocol SpecificMyelodysplastic/Myeloproliferative DiseasesCachexiaLeukemiaLymphoma
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
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)
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Floating Hospital for Children at Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Tomorrows Children's Institute at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
CHRISTUS Santa Rosa Children's Hospital
🇺🇸San Antonio, Texas, United States
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
🇺🇸San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics
🇺🇸San Antonio, Texas, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Saint Paul, Minnesota, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Tod Children's Hospital
🇺🇸Youngstown, Ohio, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
CCOP - Florida Pediatric
🇺🇸Tampa, Florida, United States
St. Joseph's Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
Children's Hospital & Research Center Oakland
🇺🇸Oakland, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States