1006 - Safety and Efficacy of an LED-Based Intraoral Device for Daily Photobiomodulation Therapy prior to Cancer Treatment for Reducing Severity of Oral Mucositis in Head and Neck Cancer Patients

Purpose/Objective(s): Oral mucositis (OM) is one of the most prevalent and debilitating toxicities of head and neck cancer (HNC) treatment. Pharmacological interventions are limited; however, supportive care treatment guidelines from the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) recommend photobiomodulation (PBM) therapy for the prevention and treatment of OM. PBM therapy utilizes non-ionizing light in the visible and near-infrared light spectra to modulate biological systems, including wound healing. The aim of this study was to evaluate the safety and efficacy of an intraoral device designed to deliver PBM therapy (660 nm, 6 J/cm²) to all oral soft tissues during a 10-minute daily treatment procedure.

Materials/Methods: This was a prospective, randomized (1:1), double-blind, sham-controlled trial (NCT03972527) across 12 US cancer centers. Eligible HNC patients received a continuous course of intensity-modulated radiation therapy (IMRT) over 6-8 weeks with or without concurrent chemotherapy. Eligibility required that at least two oral cavity sites received >50 Gray, with a maximum cumulative dose of 70 Gray administered. Pain medications and oral mouthwashes were permitted. Participants received daily 10-minute PBM therapy immediately prior to scheduled radiation therapy (RT), as well as daily and weekly assessments, and a follow up visit two weeks post-treatment.

Results: 85 subjects completed the trial. Treatment was found to be safe with no device-related adverse events and was well tolerated with 98.3% of device sessions (2,574 of 2,619) completed in full. Key findings included a statistically significant reduction in the incidence of severe oral mucositis (SOM) across 6 weeks of RT [WHO Oral Toxicity Scale Grade 3 or 4: 36.8% active vs. 57.1% sham, a 36% relative reduction; p = 0.046] and at two weeks post-treatment [10.8% active vs. 36.4% sham, a 70% relative reduction; p = 0.042]. Furthermore, active arm subjects reported statistically significant lower increases in both mouth and throat soreness [1.5 active vs. 2.2 sham (5 pt scale); p = 0.029] and throat pain [3.8 active vs. 5.3 sham (10 pt scale); p = 0.028] over 6 weeks of RT using a validated patient-reported outcome tool (Oral Mucositis Weekly Questionnaire). Among subjects starting cancer treatment without prior placement of a percutaneous endoscopic gastrostomy (PEG) feeding tube, there was a 59% reduction in PEG placements [15.2% active vs. 37% sham; p = 0.073].

Conclusion: Clinical, patient-reported and functional outcomes consistently favored the active arm. The LED-based intraoral medical device was effective in reducing SOM in subjects undergoing radiation therapy with or without concurrent chemotherapy. The device's safety, tolerability, and positive clinical outcomes suggest its potential as a promising intraoral PBM intervention for managing OM in patients undergoing HNC treatment, addressing a significant challenge in oncological supportive care.