A Pilot Study Comparing Intraoral and Transcutaneous Photobiomodulation for Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy or Chemoradiotherapy

<b>Background</b>: Photobiomodulation (PBM) therapy has shown potential in managing oral mucositis (OM), a frequent and painful side effect of radiotherapy or chemoradiotherapy in head and neck cancer patients. Although PBM is increasingly used in clinical settings, the optimal delivery method-transcutaneous or intraoral-remains undetermined. <b>Methods</b>: This prospective, single-center, randomized pilot study (clinicaltrials.gov NCT06458517) aims to compare the efficacy of transcutaneous versus intraoral PBM in preventing and managing OM in patients undergoing radiotherapy or chemoradiotherapy for cancers of the oral cavity or oropharynx. Participants will be randomized into two groups: one receiving intraoral PBM with the CareMin650™ device, and the other receiving transcutaneous PBM with the ATP38^® device. <b>Results</b>: Primary and secondary outcomes will include the incidence and severity of OM, treatment interruptions, patient-reported pain levels, and quality of life, assessed using validated tools. <b>Conclusions</b>: This study will provide comparative data on two PBM modalities, contributing to the development of standardized PBM protocols in supportive oncology care and informing future multicenter trials aimed at improving patient outcomes during radiotherapy for head and neck cancer.