Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003898
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-01
Brief Title:
Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-RP-9810 | None | None | None |