title: Oral mucositis prevention by low-level laser therapy in head-and-neck cancer patients undergoing concurrent chemoradiotherapy: a phase III randomized study.
abstract: OBJECTIVE
  Oral mucositis is a major complication of concurrent chemoradiotherapy (CRT) in head-and-neck cancer patients. Low-level laser (LLL) therapy is a promising preventive therapy. We aimed to evaluate the efficacy of LLL therapy to decrease severe oral mucositis and its effect on RT interruptions.
  
  
  METHODS
  In the present randomized, double-blind, Phase III study, patients received either gallium-aluminum-arsenide LLL therapy 2.5 J/cm(2) or placebo laser, before each radiation fraction. Eligible patients had to have been diagnosed with squamous cell carcinoma or undifferentiated carcinoma of the oral cavity, pharynx, larynx, or metastases to the neck with an unknown primary site. They were treated with adjuvant or definitive CRT, consisting of conventional RT 60-70 Gy (range, 1.8-2.0 Gy/d, 5 times/wk) and concurrent cisplatin. The primary endpoints were the oral mucositis severity in Weeks 2, 4, and 6 and the number of RT interruptions because of mucositis. The secondary endpoints included patient-reported pain scores. To detect a decrease in the incidence of Grade 3 or 4 oral mucositis from 80% to 50%, we planned to enroll 74 patients.
  
  
  RESULTS
  A total of 75 patients were included, and 37 patients received preventive LLL therapy. The mean delivered radiation dose was greater in the patients treated with LLL (69.4 vs. 67.9 Gy, p = .03). During CRT, the number of patients diagnosed with Grade 3 or 4 oral mucositis treated with LLL vs. placebo was 4 vs. 5 (Week 2, p = 1.0), 4 vs. 12 (Week 4, p = .08), and 8 vs. 9 (Week 6, p = 1.0), respectively. More of the patients treated with placebo had RT interruptions because of mucositis (6 vs. 0, p = .02). No difference was detected between the treatment arms in the incidence of severe pain.
  
  
  CONCLUSIONS
  LLL therapy was not effective in reducing severe oral mucositis, although a marginal benefit could not be excluded. It reduced RT interruptions in these head-and-neck cancer patients, which might translate into improved CRT efficacy.
authors.affiliation: Departamento de Radiologia, Disciplina de Oncologia, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
authors.forename: Aline
authors.initials: A
authors.lastname: Gouvêa de Lima
authors.forename: Rosângela Correa
authors.initials: RC
authors.lastname: Villar
authors.forename: Gilberto
authors.initials: G
authors.lastname: de Castro
authors.forename: Reynaldo
authors.initials: R
authors.lastname: Antequera
authors.forename: Erlon
authors.initials: E
authors.lastname: Gil
authors.forename: Mauro Cabral
authors.initials: MC
authors.lastname: Rosalmeida
authors.forename: Miriam Hatsue Honda
authors.initials: MH
authors.lastname: Federico
authors.forename: Igor Moisés Longo
authors.initials: IM
authors.lastname: Snitcovsky
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000532:radiotherapy / Q000556:secondary; D000328:Adult; D000368:Aged; D001835:Body Weight; D001938:Brazil; D002277:Carcinoma / Q000532:radiotherapy; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin; D003680:Deglutition Disorders / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D054023:Lasers, Semiconductor / Q000627:therapeutic use*; D028022:Low-Level Light Therapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D002945:Cisplatin