Clinical Trials Directory

Trials / Completed

CompletedNCT00003898

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

The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
1 Year – 21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTglutamineOral

Timeline

Start date
1999-01-01
Primary completion
2003-06-01
Completion
2004-01-01
First posted
2004-06-17
Last updated
2011-03-01

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00003898. Inclusion in this directory is not an endorsement.