ONCOLOGICAL SAFETY OF PHOTOBIOMODULATION THERAPY IN ORAL AND OROPHARYNGEAL SQUAMOUS CELL CARCINOMA PATIENTS: AN INTERIM ANALYSIS

Abstract

Background Photobiomodulation therapy (PBMT) has increasingly been used to manage oral toxicities secondary to cancer treatment; however, its impact on the stimulation of malignant cells is currently unknown. Objective This 4-arm, double-blind, phase III randomized controlled clinical trial (RBR-4w4wwx) was designed to assess the impact of prophylactic PBMT for oral and oropharyngeal mucositis (OM) in the survival rates of patients with oral and oropharyngeal squamous cell carcinoma (OPSCC). Methods Patients were randomly allocated to 4 groups: intraoral prophylactic PBMT (G1), placebo intraoral PBMT (G2), extraoral prophylactic PBMT (G3), and placebo extraoral PBMT (G4). OM grade (NCI) and OM-associated pain (EVA scale) were assessed weekly during OPSCC treatment. Tumor outcomes were evaluated quarterly during 12 months. Data analysis was performed using descriptive statistics. Results A total of 45 OPSCC patients were included. OM peak ulcerations (grade 2 or higher) were observed at week 3 for G1, G2, and G4 and at week 5 for G3. Placebo groups had the highest levels of pain when compared with the treatment/intervention groups (P Conclusions No negative impact of prophylactic PBMT for OM could be detected in terms OPSCC treatment outcomes.