Effectiveness of Extraoral Photobiomodulation in Management of Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy: A Multicenter, Randomized, Single-blind Clinical Trial

Objective To compare the efficacy of intraoral (IOPBM) and extraoral photobiomodulation (EOPBM) protocols in the management of OM in patients with oral and oropharyngeal (OOSCC) squamous cell carcinoma undergoing RT. Methods This is a this multicenter, randomized, blinded clinical trial. Thirty-nine patients with OOSCC treated in 3 different cancer centers in Brazil were included. After random selection, patients were divided into two groups: IOPBM Group: Intra oral application of PBM using low-level laser; EOPBM Group: Extraoral application of PBM using a defocused high-power laser. PBM therapy was performed 5 times a week during the entire RT (5 to 7 weeks) or until there were no more OM lesions. All the patients were evaluated daily, and OM was classified according to the WHO and NCI scales. In addition to OM, were evaluated: oral pain, candidiasis, trismus and functional scores (chewing, dysphagia, fluid intake and dysgeusia). Results All patients experienced some grade of OM during RT. No significant differences were observed between groups in all OM grades (WHO scale, p=0.55; NCI scale, p=0.76) and the mean time to development of ulcerative grades of OM (WHO scale, p= 0.63; NCI scale, p= 0.61). Only in the second week of RT the oral pain score was statistical lower in the IOPBM when compared in the EOPBM (p= 0.03). When dysgeusia and dysphagia were evaluated the patients in the IOPBM group had a higher mean score (p= 0.04) and (p = 0.03) when compared EOPBM group. Conclusions This study suggests that EOPBM protocol was as effective as IOPBM in the management of OM in patients undergoing RT, additionally the use of EOPBM may reduce the severity and pain associated with dysphagia. To compare the efficacy of intraoral (IOPBM) and extraoral photobiomodulation (EOPBM) protocols in the management of OM in patients with oral and oropharyngeal (OOSCC) squamous cell carcinoma undergoing RT. This is a this multicenter, randomized, blinded clinical trial. Thirty-nine patients with OOSCC treated in 3 different cancer centers in Brazil were included. After random selection, patients were divided into two groups: IOPBM Group: Intra oral application of PBM using low-level laser; EOPBM Group: Extraoral application of PBM using a defocused high-power laser. PBM therapy was performed 5 times a week during the entire RT (5 to 7 weeks) or until there were no more OM lesions. All the patients were evaluated daily, and OM was classified according to the WHO and NCI scales. In addition to OM, were evaluated: oral pain, candidiasis, trismus and functional scores (chewing, dysphagia, fluid intake and dysgeusia). All patients experienced some grade of OM during RT. No significant differences were observed between groups in all OM grades (WHO scale, p=0.55; NCI scale, p=0.76) and the mean time to development of ulcerative grades of OM (WHO scale, p= 0.63; NCI scale, p= 0.61). Only in the second week of RT the oral pain score was statistical lower in the IOPBM when compared in the EOPBM (p= 0.03). When dysgeusia and dysphagia were evaluated the patients in the IOPBM group had a higher mean score (p= 0.04) and (p = 0.03) when compared EOPBM group. This study suggests that EOPBM protocol was as effective as IOPBM in the management of OM in patients undergoing RT, additionally the use of EOPBM may reduce the severity and pain associated with dysphagia.