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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003898
First Posted: June 17, 2004
Last Update Posted: March 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Roswell Park Cancer Institute
  Purpose

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.


Condition Intervention Phase
Oral Complications Unspecified Childhood Solid Tumor, Protocol Specific Dietary Supplement: glutamine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 120
Study Start Date: January 1999
Study Completion Date: January 2004
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: glutamine
    Oral
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003898


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Barbara Jean Bambach, MD Roswell Park Cancer Institute
  More Information

Publications:
Aquino VM, Harvey A, Garvin J, et al.: The use of supplemental glutamine to decrease morbidity in children undergoing stem cell transplantation: a Pediatric Blood and Marrow Transplant Consortium study. [Abstract] 2004 Pediatric Academic Societies' Annual Meeting, May 1-4, San Francisco, California. A-1627, 2004. Availabel online Last accessed August 29, 2005.

Responsible Party: Barbara Bambech, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00003898     History of Changes
Other Study ID Numbers: CDR0000067069
RPCI-RP-9810
First Submitted: November 1, 1999
First Posted: June 17, 2004
Last Update Posted: March 1, 2011
Last Verified: February 2011

Keywords provided by Roswell Park Cancer Institute:
unspecified childhood solid tumor, protocol specific
oral complications