Sponsors

Lead Sponsor

Roswell Park Cancer Institute

OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity and duration of mucositis in children undergoing stem cell transplantation. II. Determine the safety of this regimen in these patients. III. Determine serum glutamine levels achieved during this regimen in these patients. OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to inclusion of total body irradiation in the conditioning regimen (yes vs no). Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on the day of admission for the stem cell transplant and continuing for 28 days or until hospital discharge, whichever is first. PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 2 years.

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Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation

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