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
12 Years
N/A
Both
Oral Complications
Trial Information
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
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Mark M. Schubert, DDS, MSD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1001.00
NCT ID:
NCT00024037
Start Date:
April 1995
Completion Date:
December 2002
Related Keywords:
- Oral Complications
- oral complications
- Stomatitis
- Mucositis
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
