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The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study (NCT00003898)

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.
  • : glutamine
    Oral
    Ages eligible for Study
    1 Years to 21 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    2 locations

    United States (2)
    • Roswell Park Cancer Institute
      Buffalo, New York, United States, 14263-0001
    • Simmons Cancer Center - Dallas
      Dallas, Texas, United States, 75235-9154
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 December, 1998
    Updated:
    24 February, 2011
    Participants:
    120
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