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/cm2.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/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.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.Funding: French Ministry of Health, French national funding scheme (PHRC 2008).
Highlights
Low-level laser therapy (LLLT) called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, randomised data about efficacy and safety are missing with curative dose 4 J/cm2
Our study evaluates efficacy of low-power laser therapy during concurrent Chemoradiotherapy (CRT) for patients suffering from an advanced head and neck cancer (HNC): stage III or IV
Primary endpoint was the assessment of LLLT/PBMT efficacy measured by World Health Organization (WHO) grade ≥ 3 OM incidence and duration
Summary
Low-level laser therapy (LLLT) called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, randomised data about efficacy and safety are missing with curative dose 4 J/cm. Oral mucositis (OM) is one of the most common adverse effects of chemotherapy and radiotherapy, especially for head and neck cancer (HNC). Prevalence of iatrogenic mucosal lesions depends on patient characteristics (risk factors) and treatments, with more aggressive approaches: chemotherapy in addition of radiotherapy, or targeted agents as cetuximab during radiation regimen [1, 2]. OM represents an inflammation of the oral cavity in which mucous membranes are damaged and various lesions are observed: atrophy, erythema, oedema, ulceration, bleeding (National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI - CTCAE) v4.0)
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