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Purpose To assess the feasibility, safety and tolerability of CareMin650, a new photobiomodulation device, in patients treated by radiotherapy (RT). To collect preliminary data on efficacy for prevention and treatment of oral mucositis (OM) and radiation dermatitis (RD). Methods French, multicentric, prospective, non-comparative study. Inclusion of patients with head and neck cancer (H&NC, cohort A) or breast cancer (BC, cohort B) treated in prophylactic (cohorts A1 and B1) or curative setting (cohort A2 and B2). Prophylactic treatment was administered from D1 to end of RT, at a dose of 3 J/cm 2 . Curative treatment started when a grade 1 to grade 3 lesion had occurred and was pursued until end of RT. Primary endpoint was incidence of device-related adverse events (AEs). OM and RD lesions were graded according to CTCAE V3. Results Overall, 72 patients were included (22, 9, 23 and 18 in cohorts A1, A2, B1 and B2 respectively). No device-related AE was reported after 1,312 CareMin650 sessions. In cohorts A1 and B1, median time to first OM or RD lesion was 20 days. One BC patient developed G3 RD after completion of RT and discontinuation of CareMin650. Four H&NC patients developed G3 OM. In cohorts A2 and B2, lesions improved or stabilized in 71% of patients. Rates of satisfaction were high among patients and users. Conclusion CareMin650 is feasible, safe and well tolerated for preventive or curative treatment of OM and RD in cancer patients treated with RT. Preliminary efficacy results are promising.
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Bensadoun et al. (2021) studied this question.