Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk|
- Efficacy of cyproheptadine HCl in the prevention of cancer/treatment-related weight loss, defined as weight loss ≥ 5% at the 4 or 8- week assessment when compared to baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Severity of weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Pattern of weight in the study population [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Comparison on the change for prealbumin of malnourishment and body composition between groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Comparison of the effect of cyproheptadine hydrochloride on prealbumin levels of malnourishment and on body composition within the treatment group at completion of therapy, baseline, and post-intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Comparison of the changes between those with and without weight loss within treatment groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I cyproheptadine hydrochloride
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
Drug: cyproheptadine hydrochloride
Other Name: cyproheptadine HCl
Placebo Comparator: Arm II placebo
Patients receive an oral placebo twice daily for 8 weeks.
- 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.
- 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.
|United States, California|
|Miller Children's Hospital|
|Long Beach, California, United States, 90806|
|United States, Connecticut|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|United States, Delaware|
|A.I. duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Children's Hospital of Southwest Florida at Lee Memorial|
|Fort Myers, Florida, United States, 33908|
|Nemours Children's Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32207-8482|
|Nemours Children's Clinic - Orlando|
|Orlando, Florida, United States, 32806|
|Arnold Palmer Hospital for Children|
|Orlando, Florida, United States, 32806|
|Nemours Children's Hospital Pensacola|
|Pensacola, Florida, United States, 32504|
|United States, Hawaii|
|Kapiolani Medical Center for Women and Children|
|Honolulu, Hawaii, United States, 96826|
|United States, Louisiana|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70121|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Texas|
|CHRISTUS Santa Rosa Children's Hospital|
|San Antonio, Texas, United States, 78207|
|United States, Virginia|
|Children's Hospital of The King's Daughters|
|Norfolk, Virginia, United States, 23507|
|Principal Investigator:||Jeffrey P. Krischer, PhD||University of South Florida|