A recent study by Alfeky et al. (2023), published in the Journal of Pharmaceutical Negative Results, provides new and revolutionary information on the effects of MLS® Laser Therapy on Radiation-Induced Oral Mucositis (RIOM) in Head and Neck Cancer (HNC) patients. This research, conducted using the M6 robotic device, is the first of its kind to explore this application, offering new hope to patients suffering from this debilitating side effect of radiotherapy.
Oral mucositis is a frequent and painful complication of cancer treatments, especially radiotherapy. It is characterised by inflammation and ulcers in the mucous membranes of the mouth and throat, which causes intense pain, difficulty swallowing and an increased risk of infection. Managing RIOM effectively is essential to maintain quality of life in cancer patients.
The aim of this randomised clinical trial was to compare the efficacy of MLS® Laser Therapy (Group A) with Low-Level Laser Therapy (LLLT, Group B) and a placebo laser treatment (Group C) in the treatment of RIOM. The study included 60 patients, a good sample to assess the impact of the different treatments.
The results of the study were significant and promising:
The results of the study also revealed some significant advantages of the use of MLS®:
The results of this study suggest that, although still considered an off-label application, MLS® Laser Therapy could become a new and effective approach for the management of Radiation-Induced Oral Mucositis in Head and Neck Cancer patients. This therapy not only reduces pain and the severity of mucositis, but also offers practical advantages in terms of ease of use and less risk of infection.
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Decreto Legislativo 24 febbraio 1997, n°46 Articolo 21
1. E' vietata la pubblicità verso il pubblico dei dispositivi che, secondo disposizioni adottate con decreto del Ministro della Sanità, possono essere venduti soltanto su prescrizione medica o essere impiegati eventualmente con l'assistenza di un medico o di altro professionista sanitario.
2. La pubblicità presso il pubblico dei dispositivi diversi da quelli di cui al comma 1 è soggetta ad autorizzazione del Ministero della Sanità. Sulle domande di autorizzazione esprime parere la Commissione di esperti prevista dall'articolo 6, comma 3, del decreto legislativo
30 dicembre 1992, n. 541, che a tal fine è integrata da un rappresentante del Dipartimento del Ministero della Sanità competente in materia di dispositivi medici e da uno del Ministero dell'Industria, del commercio e dell'artigianato.
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