title: Phase III trial of low-level laser therapy to prevent oral mucositis in head and neck cancer patients treated with concurrent chemoradiation.
abstract: BACKGROUND
  Oral mucositis (OM) is a complication of chemoradiotherapy treatment of head and neck squamous cell carcinoma (HNSCC) patients with no effective therapy. This study was designed to assess the efficacy of preventive low-level laser therapy (LLLT) in reducing the incidence of grade 3-4 OM.
  
  
  METHODS
  From June 2007 to December 2010, 94 HNSCC patients entered a prospective, randomized, double-blind, placebo-controlled phase III trial. Chemoradiotherapy consisted of conventional radiotherapy plus concurrent cisplatin every 3weeks. A diode InGaAlP (660nm-100mW-1J-4J/cm(2)) was used. OM evaluation was performed by WHO and OMAS scales and quality of life by EORTC questionnaires (QLQ).
  
  
  RESULTS
  A six-fold decrease in the incidence of grades 3-4 OM was detected in the LLLT group compared to the placebo; (6.4% versus 40.5%). LLLT impacted the incidence of grades 3-4 OM to a relative risk ratio of 0.158 (CI 95% 0.050-0.498). After treatment QLQ-C30 showed, differences favoring LLLT in physical, emotional functioning, fatigue, and pain; while the QLQ-H&N35 showed improvements in LLLT arm for pain, swallowing, and trouble with social eating.
  
  
  CONCLUSIONS
  Preventive LLLT in HNSCC patients receiving chemoradiotherapy is an effective tool for reducing the incidence of grade 3-4 OM. Efficacy data were corroborated by improvements seen in quality of life.
authors.affiliation: Coordination of Clinical Research, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil. Electronic address: hspindola@inca.gov.br.
authors.forename: Heliton S
authors.initials: HS
authors.lastname: Antunes
authors.forename: Daniel
authors.initials: D
authors.lastname: Herchenhorn
authors.forename: Isabele A
authors.initials: IA
authors.lastname: Small
authors.forename: Carlos M M
authors.initials: CM
authors.lastname: Araújo
authors.forename: Celia Maria Pais
authors.initials: CM
authors.lastname: Viégas
authors.forename: Elida
authors.initials: E
authors.lastname: Cabral
authors.forename: Mariana P
authors.initials: MP
authors.lastname: Rampini
authors.forename: Pedro C
authors.initials: PC
authors.lastname: Rodrigues
authors.forename: Tereza G P
authors.initials: TG
authors.lastname: Silva
authors.forename: Elza M S
authors.initials: EM
authors.lastname: Ferreira
authors.forename: Fernando L
authors.initials: FL
authors.lastname: Dias
authors.forename: Carlos G
authors.initials: CG
authors.lastname: Ferreira
mesh_terms: D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D028022:Low-Level Light Therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D000077195:Squamous Cell Carcinoma of Head and Neck; D013280:Stomatitis / Q000517:prevention & control* / Q000523:psychology
keywords: Chemotherapy; Head and neck cancer; Low-level laser therapy; Oral mucositis; Quality of life; Radiotherapy