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

Overview

Journal Radiat Oncol

Publisher Biomed Central

Specialties Oncology
Radiology

Date 2019 May 24

PMID 31118057

Citations 20

Authors

Florence Legoute

Rene-Jean Bensadoun

Valerie Seegers

Yoann Pointreau

Delphine Caron

Philippe Lang

Alain Prevost

Laurent Martin

Ulrike Schick

Benjamin Morvant

Olivier Capitain

Gilles Calais

Eric Jadaud

Affiliations

Soon will be listed here.

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/cm.

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/cm 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).

Citing Articles

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