PURPOSE: 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 AND MATERIALS: 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 receivedpreventive 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.
RCT Entities:
PURPOSE:Oral mucositis is a major complication of concurrent chemoradiotherapy (CRT) in head-and-neck cancerpatients. 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 AND MATERIALS: 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 cancerpatients, which might translate into improved CRT efficacy.
Authors: Hoon Chung; Tianhong Dai; Sulbha K Sharma; Ying-Ying Huang; James D Carroll; Michael R Hamblin Journal: Ann Biomed Eng Date: 2011-11-02 Impact factor: 3.934
Authors: Mariana de Pauli Paglioni; Carolina Guimarães Bonfim Alves; Elisa Kauark Fontes; Marcio Ajudarte Lopes; Ana Carolina Prado Ribeiro; Thaís Bianca Brandão; Cesar Augusto Migliorati; Alan Roger Santos-Silva Journal: Support Care Cancer Date: 2019-07-01 Impact factor: 3.603
Authors: Thaís Bianca Brandão; Karina Morais-Faria; Ana Carolina Prado Ribeiro; César Rivera; João Victor Salvajoli; Marcio Ajudarte Lopes; Joel B Epstein; Praveen R Arany; Gilberto de Castro; Cesar Augusto Migliorati; Alan Roger Santos-Silva Journal: Support Care Cancer Date: 2018-02-08 Impact factor: 3.603
Authors: Heliton S Antunes; Gabriel Wajnberg; Marcos B Pinho; Natasha Andressa Nogueira Jorge; Joyce Luana Melo de Moraes; Claudio Gustavo Stefanoff; Daniel Herchenhorn; Carlos M M Araújo; Celia Maria Pais Viégas; Mariana P Rampini; Fernando L Dias; Patricia Savio de Araujo-Souza; Fabio Passetti; Carlos G Ferreira Journal: Lasers Med Sci Date: 2017-08-24 Impact factor: 3.161
Authors: Yehuda Zadik; Praveen R Arany; Eduardo Rodrigues Fregnani; Paolo Bossi; Héliton Spindola Antunes; René-Jean Bensadoun; Luiz Alcino Gueiros; Alessandra Majorana; Raj G Nair; Vinisha Ranna; Wim J E Tissing; Anusha Vaddi; Rachel Lubart; Cesar Augusto Migliorati; Rajesh V Lalla; Karis Kin Fong Cheng; Sharon Elad Journal: Support Care Cancer Date: 2019-07-08 Impact factor: 3.603
Authors: Mariana de Pauli Paglioni; Karina Morais Faria; Natália Rangel Palmier; Ana Carolina Prado-Ribeiro; Reinaldo Brito E Dias; Henrique da Graça Pinto; Nathaniel Simon Treister; Joel B Epstein; César Augusto Migliorati; Alan Roger Santos-Silva; Thais Bianca Brandão Journal: Lasers Med Sci Date: 2020-07-05 Impact factor: 3.161
Authors: Cesar Migliorati; Ian Hewson; Rajesh V Lalla; Heliton Spindola Antunes; Cherry L Estilo; Brian Hodgson; Nilza Nelly Fontana Lopes; Mark M Schubert; Joanne Bowen; Sharon Elad Journal: Support Care Cancer Date: 2012-09-22 Impact factor: 3.603