Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.
PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.
|Leukemia Lymphoma Malnutrition Myelodysplastic Syndromes Unspecified Childhood Solid Tumor, Protocol Specific Weight Changes||Dietary Supplement: Ensure Dietary Supplement: PediaSure Drug: cyproheptadine hydrochloride||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||An Open Label Randomized Phase II Study of an Appetite Stimulant, Cyproheptadine Hydrochloride, With and Without a Nutritional Supplement, in Children With Cancer/Treatment-Related Weight Loss|
- Difference Between Measures of Weight at Baseline and at Week 24 [ Time Frame: 24 weeks ]Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.
- Body Mass Index as Assessed at Baseline and 24 Weeks [ Time Frame: 24 weeks ]Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.
- Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition [ Time Frame: 24 weeks ]
- Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24 [ Time Frame: 24 weeks ]
- Change in Weight for Age Z-score From Baseline Through 24 Weeks [ Time Frame: Baseline and 24 weeks ]Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.
|Study Start Date:||September 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I- cyproheptadine hydrochloride
Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Drug: cyproheptadine hydrochloride
Other Name: cyproheptadine HCl
Experimental: cyproheptadine HCl & PediaSure or Ensure
Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Dietary Supplement: Ensure
Other Name: nutritional supplement drinkDietary Supplement: PediaSure
Other Name: nutritional supplement drink (pediatric)Drug: cyproheptadine hydrochloride
Other Name: cyproheptadine HCl
- To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss.
- To compare patterns of body composition and weight change in patients treated with these regimens.
- To compare the change in the relationship between pre-albumin (biomarker of malnutrition) and weight improvement from baseline to the completion of study treatment.
- To compare the change in quality of life as measured by the Pediatric Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center and steroid use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
- Arm II: Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
Patients undergo blood sample collection to assess pre-albumin levels at baseline and at weeks 4 and 24. Patients also undergo assessment of body composition, lean body mass, and percentage of body fat at baseline and at weeks 4 and 24 and assessment of weight and height at baseline and at weeks 4, 8, 12, 16, 20, and 24. Patients also complete a food diary twice a week during study treatment.
Patients 7-17 years of age complete a quality-of-life questionnaire at baseline and at weeks 4 and 24.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949117
|Study Chair:||Marisa Couluris, DO||University of South Florida|