Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial
Abstract Background Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J...
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doaj-8ebc9cf20d934514a65702da74292e082020-11-25T02:33:17ZengBMCRadiation Oncology1748-717X2019-05-0114111110.1186/s13014-019-1292-2Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trialFlorence Legouté0René-Jean Bensadoun1Valérie Seegers2Yoann Pointreau3Delphine Caron4Philippe Lang5Alain Prévost6Laurent Martin7Ulrike Schick8Benjamin Morvant9Olivier Capitain10Gilles Calais11Eric Jadaud12Département de Radiothérapie, Institut de Cancérologie de l’Ouest - Paul PapinCentre de haute énergie – Oncologie-radiothérapieInstitut de Cancérologie de l’Ouest - Paul Papin, Direction de la Recherche clinique et de l’innovationCentre Jean-Bernard - Clinique Victor-HugoDépartement de Radiothérapie, Institut de Cancérologie de l’Ouest - Paul PapinSite intégré d’Oncologie - Groupe hospitalier Pitié-SalpétrièreDépartement de Radiothérapie, Institut Jean GodinotCentre de Radiothérapie Guillaume le ConquérantDépartement de Radiothérapie, Centre Hospitalier Universitaire de Brest, Hôpital MorvanDépartement de pathologie cellulaire et tissulaire, Centre Hospitalier Universitaire d’AngersDépartement d’Oncologie médicale, Institut de Cancérologie de l’Ouest - Paul PapinDépartement de Radiothérapie, Institut de Cancérologie de l’Ouest - Paul PapinDépartement de Radiothérapie, Institut de Cancérologie de l’Ouest - Paul PapinAbstract Background Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm2. Methods This phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed. Results Among 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT. Conclusions This study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment. Trial registration ClinicalTrials.gov Identifier: NCT01772706. Title: Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite). Study Start Date: October 2008. Primary Completion Date: October 2016. Responsible Party: Institut de Cancérologie de l’Ouest – Paul Papin. Principal Investigator: Eric Jadaud, M.D., Institut de Cancérologie de l’Ouest – Paul Papin. Funding: French Ministry of Health, French national funding scheme (PHRC 2008).http://link.springer.com/article/10.1186/s13014-019-1292-2Oral mucositisChemoradiotherapyHead and neck cancerLasertherapySupportive care |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Florence Legouté René-Jean Bensadoun Valérie Seegers Yoann Pointreau Delphine Caron Philippe Lang Alain Prévost Laurent Martin Ulrike Schick Benjamin Morvant Olivier Capitain Gilles Calais Eric Jadaud |
spellingShingle |
Florence Legouté René-Jean Bensadoun Valérie Seegers Yoann Pointreau Delphine Caron Philippe Lang Alain Prévost Laurent Martin Ulrike Schick Benjamin Morvant Olivier Capitain Gilles Calais Eric Jadaud Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial Radiation Oncology Oral mucositis Chemoradiotherapy Head and neck cancer Lasertherapy Supportive care |
author_facet |
Florence Legouté René-Jean Bensadoun Valérie Seegers Yoann Pointreau Delphine Caron Philippe Lang Alain Prévost Laurent Martin Ulrike Schick Benjamin Morvant Olivier Capitain Gilles Calais Eric Jadaud |
author_sort |
Florence Legouté |
title |
Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial |
title_short |
Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial |
title_full |
Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial |
title_fullStr |
Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial |
title_full_unstemmed |
Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial |
title_sort |
low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase iii trial |
publisher |
BMC |
series |
Radiation Oncology |
issn |
1748-717X |
publishDate |
2019-05-01 |
description |
Abstract Background Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm2. Methods This phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed. Results Among 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT. Conclusions This study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment. Trial registration ClinicalTrials.gov Identifier: NCT01772706. Title: Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite). Study Start Date: October 2008. Primary Completion Date: October 2016. Responsible Party: Institut de Cancérologie de l’Ouest – Paul Papin. Principal Investigator: Eric Jadaud, M.D., Institut de Cancérologie de l’Ouest – Paul Papin. Funding: French Ministry of Health, French national funding scheme (PHRC 2008). |
topic |
Oral mucositis Chemoradiotherapy Head and neck cancer Lasertherapy Supportive care |
url |
http://link.springer.com/article/10.1186/s13014-019-1292-2 |
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