Clinical trial NCT00949117
Conditions: Leukemia Lymphoma Malnutrition Myelodysplastic Syndromes Unspecified Childhood Solid Tumor, Protocol Specific Weight Changes
Keywords: malnutrition weight changes childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia untreated childhood acute myeloid leukemia other myeloid malignancies stage I childhood Hodgkin lymphoma stage II childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent childhood anaplastic large cell lymphoma stage I childhood anaplastic large cell lymphoma stage II childhood anaplastic large cell lymphoma stage III childhood anaplastic large cell lymphoma stage IV childhood anaplastic large cell lymphoma recurrent childhood grade III lymphomatoid granulomatosis childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma recurrent childhood large cell lymphoma stage I childhood large cell lymphoma stage II childhood large cell lymphoma stage III childhood large cell lymphoma stage IV childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma childhood nasal type extranodal NK/T-cell lymphoma childhood Burkitt lymphoma recurrent childhood small noncleaved cell lymphoma stage I childhood small noncleaved cell lymphoma stage II childhood small noncleaved cell lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma childhood myelodysplastic syndromes de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes unspecified childhood solid tumor, protocol specific
Sponsor: University of South Florida
Start date: 2009-09-01; Completion date: 2011-11-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity. arm 2: 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.
Interventions: intervention 1: Ensure intervention 2: PediaSure intervention 3: cyproheptadine hydrochloride
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally

Protocol documents: