Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system
in children who are undergoing stem cell transplantation.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in
reducing inflammation of the mouth and digestive system in children who are undergoing
peripheral stem cell transplantation.
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.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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