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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003898
• Other study ID #: CDR0000067069
• Secondary ID: RPCI-RP-9810
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 25, 2011
• Start date: January 1999
• Est. completion date: January 2004

Study information

• Verified date: February 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2004
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 21 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Oral Complications
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Dietary Supplement:
• glutamine
Oral

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Simmons Cancer Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH, Jackson GB, Sandler ES. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a — View Citation