Abstract
<h3>Objectives</h3> This randomized double-blind clinical trial aimed to assess the effect of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral mucositis (OM) on clinical outcomes and survival in patients with oral cavity and oropharyngeal squamous cell carcinoma (OOPSCC). <h3>Study Design</h3> Patients with OOPSCC who received radiotherapy (RT) with curative intent were randomized into 2 groups. One received prophylactic extraoral PBM (LED 69 diode, 34 × 660 nm and 35 × 850 nm, 1390 mW, 50 mW/cm<sup>2</sup>, 3.0 J of energy/cm<sup>2</sup>, 60 s/spot) and the other placebo. OM grade (NCI, Version 4.0), pain (visual analog scale), analgesia, and anti-inflammatory prescriptions were assessed weekly. Quality of life (QoL) evaluations were performed on the first and last days of RT. The effect of PBM on cancer treatment outcomes was evaluated quarterly after RT. <h3>Results</h3> Fifty-five patients were included. Later OM onset, lower mean pain scores, and less analgesics and anti-inflammatory prescriptions were observed for the PBM group. Better QoL scores were observed for the PBM group. There were no significant adverse side effects or effects on overall survival. <h3>Conclusions</h3> Prophylactic extraoral PBM may be effective and safe for mitigating OM outcomes in patients with oral squamous cell carcinoma.
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