Lymphoma Clinical Trial
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
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.
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 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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