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
OBJECTIVES:
Primary
- 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.
Secondary
- 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 Peds-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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Difference between measures of weight at baseline and at week 4
24 weeks
No
Marisa Couluris, DO
Study Chair
University of South Florida
United States: Data and Safety Monitoring Board
SCUSF 0802
NCT00949117
September 2009
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