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Radiat Oncol. 2019 May 22;14(1):83. doi: 10.1186/s13014-019-1292-2.

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.

Author information

1
Département de Radiothérapie, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France. florence.legoute@ico.unicancer.fr.
2
Centre de haute énergie - Oncologie-radiothérapie, 10 boulevard Pasteur, F-06000, Nice, France.
3
Institut de Cancérologie de l'Ouest - Paul Papin, Direction de la Recherche clinique et de l'innovation, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.
4
Centre Jean-Bernard - Clinique Victor-Hugo, 9 rue Beauverger, F-72000, Le Mans, France.
5
Département de Radiothérapie, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.
6
Site intégré d'Oncologie - Groupe hospitalier Pitié-Salpétrière, 47-83 boulevard de l'Hôpital, F-75651 Cedex 13, Paris, France.
7
Département de Radiothérapie, Institut Jean Godinot, 1 avenue du Général Koenig, F-51056, Reims, France.
8
Centre de Radiothérapie Guillaume le Conquérant, 61 rue Denfert Rochereau, F-76600, Le Havre, France.
9
Département de Radiothérapie, Centre Hospitalier Universitaire de Brest, Hôpital Morvan, 2 avenue Foch, F-29200, Brest, France.
10
Département de pathologie cellulaire et tissulaire, Centre Hospitalier Universitaire d'Angers, 4 rue Larrey, F-49933, Cedex 09, Angers, France.
11
Département d'Oncologie médicale, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.

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).

KEYWORDS:

Chemoradiotherapy; Head and neck cancer; Lasertherapy; Oral mucositis; Supportive care

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