Extraoral Photobiomodulation for Prevention of Oral and Oropharyngeal Mucositis in Head and Neck Cancer Patients: Interim Analysis of A Randomized, Double-Blind, Clinical Trial

Abstract

\n PurposeTo assess the safety and efficacy of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral and oropharyngeal mucositis (OM) on clinical outcomes and survival in patients with oral cavity and oropharyngeal squamous cell carcinoma (OOPSCC).MethodsOOPSCC patients who received radiotherapy (RT) were prospectively randomized to two groups: prophylactic extraoral PBM and placebo. OM grade (NCI), pain (VAS), analgesia, and anti-inflammatory prescriptions were assessed weekly. Quality of life questionnaires (QoL) were performed at the first and last day of RT. Following RT, participants were evaluated quarterly for oncological outcomes follow-up.Results55 patients met the inclusion criteria. The first occurrence of OM was observed at week 1, for the placebo group (p\u2009=\u20090.014). Later OM onset and severity was observed for the PBM group, with first occurrence at week 2 (p\u2009=\u20090.009). No difference in severe OM incidence was observed (p\u2009>\u20090.05). Lower mean pain score was noted at week 7 for the PBM group (2.1) compared to placebo group (4.5) (p\u2009=\u20090.009). Less analgesics (week 3; p\u2009=\u20090.009/week 7; p\u2009=\u20090.02) and anti-inflammatory prescription (week 5; p\u2009=\u20090.0346) were observed for the PBM group. Better QoL scores were observed for the PBM group at last day of RT (p\u2009=\u20090.0034). No difference in overall survival among groups, was observed in one year of follow-up (p\u2009=\u20090.889).ConclusionProphylactic extraoral PBM can delay OM onset, reduce pain, as well as reduced analgesic and anti-inflammatory prescription requirements. Extraoral PBM was associated with better QoL. There was no evidence of PBM impact on oncological outcomes. TRN:RBR-4w4swx (date of registration: 01/20/2020)