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Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
This study is ongoing, but not recruiting participants.
Study NCT00024037   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: May 9, 2009   History of Changes

September 13, 2001
May 9, 2009
April 1995
 
 
 
Complete list of historical versions of study NCT00024037 on ClinicalTrials.gov Archive Site
 
 
 
Laser Therapy in Preventing Oral Mucositis in Patients Undergoing Bone Marrow Transplantation
A Phase II/III 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

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 II/III trial to determine the effectiveness of laser therapy in preventing oral mucositis in patients who are undergoing bone marrow transplantation.

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.

Phase II, Phase III
Interventional
Supportive Care
Oral Complications
Procedure: management of therapy complications
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS: At risk of developing oral mucositis due to toxicity resulting from one of the following: Preparative chemoradiotherapy Multiple drug conditioning regimens Graft-versus-host disease (GVHD) prophylaxis

PATIENT CHARACTERISTICS: Age: Over 12 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to carry out routine oral care No active oral, viral, bacterial, or fungal infections No active uncontrolled oral bleeding that would preclude laser therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Not currently enrolled on other protocols with oral mucositis as a stated end point (e.g., conditioning regimen toxicity trials or GVHD prophylaxis trials) No other concurrent investigational drugs or agents for the prevention or treatment of mucositis No concurrent photosensitizing agents

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00024037
 
CDR0000068886, FHCRC-1001.00, NCI-G01-2008
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Mark M. Schubert, DDS, MSD Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
February 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP