Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation
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.
|Oral Complications Unspecified Childhood Solid Tumor, Protocol Specific||Dietary Supplement: glutamine||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|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 Start Date:||January 1999|
|Study Completion Date:||January 2004|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
Dietary Supplement: glutamine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003898
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|Study Chair:||Barbara Jean Bambach, MD||Roswell Park Cancer Institute|