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.

Condition	Treatment or Intervention	Phase
oral complications of cancer and cancer therapy	Procedure: Low-energy laser therapy	Phase II Phase III

Further Study Details: 

OBJECTIVES: I. Determine whether low-energy laser therapy can prevent oral mucositis in patients undergoing bone marrow transplantation.

PROTOCOL 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.

Ages Eligible for Study:  12 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• 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

--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

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States

Study chairs or principal investigators

Mark M. Schubert,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000068886; FHCRC-1001.00; NCI-G01-2008
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024037
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08