Two recently published studies conducted by PhD Jolien Robijns – already the team leader in several research projects on the efficacy and safety of treatment with photobiomodulation (PBMT) in the prevention of side effects related to radiotherapy and chemotherapy - have investigated the efficacy of MLS® Laser Therapy in the prevention of acute radiodermatitis in patients with breast cancer undergoing hypofractionated radiotherapy and in the long-term safety of the treatment in patients treated with conventional fractionated radiotherapy.
The first study, a randomised controlled multicentre LABRA-trial, involved 86 patients divided into two groups. The control group received a standard topical skin treatment while the treatment group additionally received MLS® Laser Therapy with the M6 device for 4 weeks. The results showed a lower incidence of acute radiodermatitis and wet desquamation in the PBMT group than in the control group.
“Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole-breast irradiation (LABRA trial).”
Robijns, Jolien et al.
Lasers in surgery and medicine vol. 54,3 (2022): 374-383. doi:10.1002/lsm.23475
The second research, an extension of the previous TRANSDERMIS-trial, validated the safety 5 years after treatment with MLS® Laser Therapy, applied for the prevention of radiodermatitis. There was no significant difference between the group of patients treated with MLS® Laser Therapy compared with the untreated ones in terms of locoregional recurrences (DFS - disease‐free survival), development of new primary tumours (CFS - cancer‐free survival) or survival in general (OS - overall survival). Patients were monitored every six months from April 2015 to May 2022 by means of clinical evaluation, blood tests and mammography.
“A long-term follow-up of early breast cancer patients treated with photobiomodulation during conventional fractionation radiotherapy in the prevention of acute radiation dermatitis.”
Robijns, Jolien et al.
Lasers in surgery and medicine vol. 54,10 (2022): 1261-1268. doi:10.1002/lsm.23608
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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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