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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


Phase 2/Phase 3
12 Years
N/A
Not Enrolling
Both
Oral Complications

Thank you

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 CenterSeattle, Washington  98109