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
Legouté F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prévost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E
Radiation oncology (London, England) · 42 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- University or hospital
- Programme hospitalier de Recherche clinique
Based on 1 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2019-05-22 · Radiat Oncol · vol. 14 · issue 1 · p. 83
- Publisher
- BioMed Central
- Cited
- 112 citations · more than 96% of similar papers · 5.1× the field average
- Impact
- Top 10% most cited in its field
- References
- 39 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Oral health in cancer treatment · Laser Applications in Dentistry and Medicine · Head and Neck Cancer Studies
- Keywords
- Medicine, Mucositis, Chemoradiotherapy, Head and neck cancer, Placebo, Surgery, Incidence (geometry), Clinical endpoint, Population, Low level laser therapy, Internal medicine, Randomized controlled trial, Radiation therapy, Laser therapy
- MeSH
- humans, carcinoma, squamous cell, head and neck neoplasms, stomatitis, prognosis, severity of illness index, quality of life, aged, middle aged, female, male, chemoradiotherapy, low-level light therapy
13 authors
From FR
- Florence Legouté · correspondingInstitut de Cancérologie de l'Ouest
- René‐Jean BensadounCentre de Haute Energie
- Valérie SeegersInstitut de Cancérologie de l'Ouest
- Y. PointreauCentre Jean Bernard; Clinique Victor Hugo
- Delphine CaronInstitut de Cancérologie de l'Ouest
- Philippe LangAssistance Publique – Hôpitaux de Paris
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).
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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