Spots Global Cancer Trial Database for Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation

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Trial Identification

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

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

Study ID: NCT00003898

Conditions

Oral Complications

Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

glutamine

Study Description

Brief Summary: 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.

Detailed Description: 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.