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
  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: 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

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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
Study First Received: November 1, 1999
Last Updated: February 25, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014