Evidence map›Paper›PMID 31118057›Full record

Trial reportRadiation oncology (London, England)2019

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.

Florence Legouté, René-Jean Bensadoun, Valérie Seegers, Yoann Pointreau, Delphine Caron, Philippe Lang, Alain Prévost, Laurent Martin, Ulrike Schick, Benjamin Morvant and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 29 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 7 pooled it
5.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01772706 nacompletednot on this map

A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.

TypeinterventionalSponsorInstitut Cancerologie de l'OuestRan2008 to 2020Enrolled97ConditionsOral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Oral MucositisArmslow level laser therapy, placebo (laser low level energy nonfunctional)
NCT07566637 nacompletednot on this mapstarted 2024, after this paper: background citation

Low-Intensity Laser Therapy Versus Proprioceptive Neuromuscular Facilitation for Pain and Disability in Chronic Non-Specific Neck Pain: A Randomized Controlled Trial

TypeinterventionalSponsorIstanbul Gedik UniversityRan2024 to 2026Enrolled75ConditionsNon Specific Neck PainArmsLow-intensity Laser Therapy Treatment, Proprioceptive Neuromuscular Facilitation Technique, Conventional physiotherapy
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 7 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. Photobiomodulation for oral mucositis in cancer care: prevention, clinical management, and evidence from randomized controlled trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  5. Photobiomodulation therapy for the prevention of acute radiation dermatitis: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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  8. Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
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  13. Current Research in Drug-Free Cancer Therapies.Bioengineering (Basel, Switzerland) · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 1 country.

Florence LegoutéDépartement 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.ORCID http://orcid.org/0000-0002-7652-0120
René-Jean BensadounCentre de haute énergie - Oncologie-radiothérapie, 10 boulevard Pasteur, F-06000, Nice, France.
Valérie SeegersInstitut 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.
Yoann PointreauCentre Jean-Bernard - Clinique Victor-Hugo, 9 rue Beauverger, F-72000, Le Mans, France.
Delphine CaronDépartement de Radiothérapie, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.
Philippe LangSite intégré d'Oncologie - Groupe hospitalier Pitié-Salpétrière, 47-83 boulevard de l'Hôpital, F-75651 Cedex 13, Paris, France.
Alain PrévostDépartement de Radiothérapie, Institut Jean Godinot, 1 avenue du Général Koenig, F-51056, Reims, France.
Laurent MartinCentre de Radiothérapie Guillaume le Conquérant, 61 rue Denfert Rochereau, F-76600, Le Havre, France.
Ulrike SchickDépartement de Radiothérapie, Centre Hospitalier Universitaire de Brest, Hôpital Morvan, 2 avenue Foch, F-29200, Brest, France.
Benjamin MorvantDépartement de pathologie cellulaire et tissulaire, Centre Hospitalier Universitaire d'Angers, 4 rue Larrey, F-49933, Cedex 09, Angers, France.
Olivier CapitainDépartement d'Oncologie médicale, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.
Gilles CalaisDépartement de Radiothérapie, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.
Eric JadaudDépartement de Radiothérapie, Institut de Cancérologie de l'Ouest - Paul Papin, 15 rue André Boquel, F-49055 Cedex 02, Angers, France.
Institut de Cancérologie de l'Ouest · FRAssistance Publique – Hôpitaux de Paris · FRCentre de Haute Energie · FRCentre de Radiothérapie Bayard · FRCentre Hospitalier Régional Universitaire de Brest · FRCentre Hospitalier Universitaire d'Angers · FRCentre Jean Bernard · FRInstitut Jean Godinot · FR

Funding

Programme hospitalier de Recherche clinique PHRC national 2008
6 · The paper itself

Abstract

backgroundLow-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

methodsThis 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

resultsAmong 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.

conclusionsThis 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 registrationClinicalTrials.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.

fundingFrench Ministry of Health, French national funding scheme (PHRC 2008).

Indexed as

Quality of LifeAgedCarcinoma, Squamous CellChemoradiotherapyFemaleHead and Neck NeoplasmsHumansLow-Level Light TherapyMaleMiddle AgedPrognosisSeverity of Illness IndexStomatitisChemoradiotherapyHead and neck cancerLasertherapyOral mucositisSupportive care

Identifiers

PMID31118057
PMCPMC6530019
OpenAlexW2946184887

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.