Oncological safety of extraoral photobiomodulation in patients with oral and oropharyngeal squamous cell carcinoma

Abstract

Aims: To assess, at clinical and molecular levels, the impact of prophylactic low-level laser therapy (photobiomodulation) for oral and oropharyngeal mucositis (OM) in the survival rates of patients with oral cavity and oropharyngeal squamous cell carcinoma (OSCC). Patients and Methods: 60 patients diagnosed with OSCC that will initiate curative protocols of adjuvant radiotherapy (RT) or chemoradiotherapy (CRT) will be prospectively assessed. Patients will be randomly allocated into two groups; Extraoral prophylactic photobiomodulation (n=30) (LED 69 diode, 34x660 nm (10 mW) and 35x850 nm (30 mW), 1390 mW, energy density 50 mW /cm2, 3.0J of energy/cm2, 60s/spot, spot size (6 cm2) and Placebo extraoral photobiomodulation sham laser (n=30). OM degree and OM associated pain will be assessed daily during the RT (NCI, Version 4.0, 2010; WHO, 1975 e VAS). The impact of the photobiomodulation will be evaluated quarterly during 18 months following RT conclusion, regarding the following oncological outcomes: local recurrences, development of second primary tumors, mean time of disease free survival and overall survival. Expected results: To contribute to a better understanding, in oncological terms, of the safety of photobiomodulation protocols regarding RT induced OM. (AU)