From clinic to couch: a pilot study of home-use photobiomodulation for radiation-induced oral mucositis and dermatitis.

PURPOSE: Radiation-induced oral mucositis (OM) and dermatitis (RD) are common debilitating toxicities of radiotherapy (RT) for head and neck cancer (HNC) patients. While photobiomodulation (PBM) has shown promise in reducing severity of these adverse effects, in-clinic treatments pose logistic and financial challenges. This study assessed the feasibility and compliance of a home-use, self-applied near-infrared PBM device for the prevention and treatment of RT-induced OM and RD.

METHODS

This prospective, single-arm trial enrolled 20 HNC patients scheduled for intensity-modulated RT (IMRT) with or without concurrent chemotherapy. Seventeen patients were analyzed following exclusions. Participants self-administered PBM at home twice daily for 9-11 weeks, from RT initiation to four weeks post-RT. The primary outcome was compliance (≥ 50% of expected treatments). Secondary outcomes included incidence of severe (grade 3-4) OM and RD.

RESULTS

67% of the participants completed at least 50% of the prescribed PBM treatments. Overall, 60% of expected sessions were administered, surpassing the predefined compliance threshold. By week 3, 6% presented with severe OM and none with severe RD. At RT completion, 41% and 18% had severe OM and RD, respectively. Four weeks post-RT, no severe OM or RD were observed, with the majority presenting with no toxicity (grade 0). No device related adverse effects were reported, and patients reported high comfort and ease of use.

CONCLUSION

Self-administered, home-use PBM is a feasible and well-tolerated approach that shows promise as pre-emptive treatment for RT induced OM and RD. Large-scale, randomized, placebo-controlled trials are needed to confirm these findings and evaluate long-term benefits.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05176834. Registration Date: December 13th, 2021.