Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation
- Conditions
- Oral ComplicationsUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00003898
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States