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

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003898
First received: November 1, 1999
Last updated: February 25, 2011
Last verified: February 2011
History of Changes

November 1, 1999
February 25, 2011
January 1999
June 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003898 on ClinicalTrials.gov Archive Site
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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

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Oral Complications
  • Unspecified Childhood Solid Tumor, Protocol Specific
Dietary Supplement: glutamine
Oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2004
June 2003   (final data collection date for primary outcome measure)

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
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003898
CDR0000067069, RPCI-RP-9810
Yes
Barbara Bambech, MD, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Study Chair: Barbara Jean Bambach, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP