The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study
1 Year
21 Years
Both
Oral Complications, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Undergoing allogeneic or autologous stem cell transplant
(including bone marrow, cord blood, or peripheral blood stem cells) Conditioning regimen
must have at least 50% risk of grade III or IV mucositis No grade III or IV hepatic
toxicity
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics Renal: Not
specified Other: No grade III or IV toxicity at admission for stem cell transplant No
altered mental status
PRIOR CONCURRENT THERAPY: No concurrent vancomycin paste or nonabsorbable antibiotics
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Barbara Jean Bambach, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000067069
NCT ID:
NCT00003898
Start Date:
January 1999
Completion Date:
January 2004
Related Keywords:
- Oral Complications
- Unspecified Childhood Solid Tumor, Protocol Specific
- unspecified childhood solid tumor, protocol specific
- oral complications
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
