Original Article

Supportive Care in Cancer

, Volume 15, Issue 10, pp 1145-1154

First online:

A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation

  • Mark M. SchubertAffiliated withDepartment of Oral Medicine, Seattle Cancer Care Alliance, University of WashingtonFred Hutchinson Cancer Research CenterOral Medicine Service, Seattle Cancer Care Alliance Email author 
  • , Fernanda P. EduardoAffiliated withLELO-FOUSP, University of Sao Paulo
  • , Katherine A. GuthrieAffiliated withFred Hutchinson Cancer Research Center
  • , Jean-Claude FranquinAffiliated withIMEB Laboratory Faculte d’Odontologie de Marseille, Universite de la Mediterranee
  • , Rene-Jean J. BensadounAffiliated withExternal Radiotherapy Unit, Centre Antoine-Lacassagne
  • , Cesar A. MiglioratiAffiliated withNSU College of Dental Medicine
  • , C. Michele E. LloidAffiliated withOral Medicine Service, Seattle Cancer Care Alliance
  • , Carlos P. EduardoAffiliated withLELO-FOUSP, University of Sao PauloUniversity of Sao Paulo
  • , Niccoli-Filho WalterAffiliated withSchool of Dentistry, Sao Paulo State University, Sao Jose dos Campos
    • , Marcia M. MarquesAffiliated withUniversity of Sao Paulo
    • , Mohd HamdiAffiliated withFradama, S.A.

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Abstract

Introduction

Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.

Materials and methods

Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm2. Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.

Results

The 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.

Discussion

While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM.

Keywords

Low level laser Mucositis prevention Hematopoietic cell transplant