Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024037
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
2001-09-13
Brief Title:
Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase IIIII Blinded Randomized Trial to Determine the Efficacy of Low Energy Diode Laser Therapy 650 nm or 780 nm to Prevent Oral Mucositis Following Bone Marrow Transplantation
Status:
COMPLETED
Status Verified Date:
2010-06
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 Laser therapy may reduce the severity of symptoms and speed healing of oral mucositis It is not yet known if laser therapy is effective in preventing oral mucositis
PURPOSE Randomized phase IIIII trial to determine the effectiveness of laser therapy in preventing oral mucositis in patients who are undergoing bone marrow transplantation
PURPOSE Randomized phase IIIII trial to determine the effectiveness of laser therapy in preventing oral mucositis in patients who are undergoing bone marrow transplantation
Detailed Description:
OBJECTIVES I Determine whether low-energy laser therapy can prevent oral mucositis in patients undergoing bone marrow transplantation
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to one of three treatment arms Arm I Patients undergo low-energy laser therapy with visible red light 650 nm daily over 15-20 minutes beginning on the first day of their transplant conditioning regimen and continuing until day 2 after bone marrow transplantation Arm II Patients undergo low-energy laser therapy with invisible infra-red light 780 nm daily on the same schedule as in arm I Arm III Patients undergo sham laser therapy daily on the same schedule as in arm I Patients are followed on days 3 7 10 14 18 21 and 24
PROJECTED ACCRUAL A total of 66 patients 22 per treatment arm will be accrued for this study
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to one of three treatment arms Arm I Patients undergo low-energy laser therapy with visible red light 650 nm daily over 15-20 minutes beginning on the first day of their transplant conditioning regimen and continuing until day 2 after bone marrow transplantation Arm II Patients undergo low-energy laser therapy with invisible infra-red light 780 nm daily on the same schedule as in arm I Arm III Patients undergo sham laser therapy daily on the same schedule as in arm I Patients are followed on days 3 7 10 14 18 21 and 24
PROJECTED ACCRUAL A total of 66 patients 22 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068886 | REGISTRY | PDQ | None |
| FHCRC-100100 | None | None | None |
| NCI-G01-2008 | None | None | None |