Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
- Registration Number
- NCT01132547
- Lead Sponsor
- University of South Florida
- Brief Summary
RATIONALE: Cyproheptadine hydrochloride 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 hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
* Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.
OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.
* Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
* Arm II: Patients receive an oral placebo twice daily for 8 weeks.
Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 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 and 8 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 levels.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II placebo placebo Patients receive an oral placebo twice daily for 8 weeks. Arm I cyproheptadine hydrochloride cyproheptadine hydrochloride Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
- Primary Outcome Measures
Name Time Method Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline 8 weeks Severity of Weight Loss Baseline and 8 weeks Change from Baseline in Weight Z score
- Secondary Outcome Measures
Name Time Method Pattern of Weight in the Study Population Baseline and 8 weeks Change from Baseline in Weight
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (14)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Children's Hospital of Southwest Florida at Lee Memorial
🇺🇸Fort Myers, Florida, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
A.I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
Nemours Children's Hospital Pensacola
🇺🇸Pensacola, Florida, United States
Nemours Children's Clinic - Orlando
🇺🇸Orlando, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
CHRISTUS Santa Rosa Children's Hospital
🇺🇸San Antonio, Texas, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Nemours Children's Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States