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
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