P. Martin1, M. Beckett1, S. Johnson-Obaseki2, J. Hilton3, M. Vickers3, P. Boulianne4, K. Dennis1, and M. Gaudet1; 1Division of Radiation Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, ON, Canada, 2Division of Head and Neck Surgery, The Ottawa Hospital and the University of Ottawa, Ottawa, ON, Canada, 3Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, ON, Canada, 4Division of Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, ON, Canada
Purpose/Objective(s):Radiotherapy for Head and Neck cancers, although effective, comes with a significant toxicity burden. Grade 3 mucositis occurs in approximately 40% of these patients. Multiple clinical trials and systemic reviews have shown that Photobiomodulation (PBM) can prevent the onset of severe mucositis. Most studies have utilized resource-intense, clinician-administered intra-oral application thus far. The purpose of our study was to evaluate the rate of mucositis in patients treated with handheld external PBM applicators.Materials/
Methods: Patients with histological diagnosis of oral cavity SCC with no evidence of macroscopic residual disease post-operatively were included in a prospective trial. All patients received 1 PBM treatment prior to start of RT and 3 treatments weekly during RT using external application with a commercially available PBM unit. The primary objective was to determine the cumulative incidence of acute grade 3 mucositis during radiotherapy and for one month following radiotherapy. Secondary objectives were to determine the cumulative incidence of acute dermatitis, late subcutaneous neck fibrosis, and late mucosal or skin telangiectasia. We also prospectively collected QOL questionnaires (ESAS, FACT-HN, and EQ-5D) to assess for any other changes. Results: A total of 22 of the 25 enrolled patients were analyzed for primary outcome. The cumulative incidence of grade 3 induced mucositis was 18.2 % (4/22) during RT, with a 9.1% (2/22) prevalence at 7/14 days post-RT and a 0% (0/22) prevalence at 1-month post-RT. The cumulative incidence of severe dermatitis was 9.1 % (2/22) during RT. No PBM-related side effects were found, and 95.5 % (21/22) of our patients were able to complete treatments. Conclusion: Preliminary analysis shows at least a 2-fold reduction of induced mucositis during RT with external PBM compared to historical rates. Patients tolerated the procedure very well without any reported side effects. The use of external PBM is much more applicable to the Canadian context and warrants further investigation, including the feasibility of patient self-administration.