About this trial
The goal of this study is to describe the effect of photobiomodulation (PBM) on the incidence and severity of oral mucositis in post-operative oral cancer patients receiving radiotherapy +/- chemotherapy.
Participants will receive PBM treatment five times a week throughout the course of their radiotherapy.
The main question it aims to answer is whether photobiomodulation reduces the incidence and severity of oral mucositis.
Eligibility criteria
Qualifiers
Patient has provided written informed consent using the PBM PICF
Age ≥ 18 years of age at Screening
Histological diagnosis of HNC of the oral cavity with no evidence of macroscopic or microscopic residual disease post-surgery (R0 or R1 resection) with histopathological confirmation and no gross residual lymphadenopathy in the planned PBM treatment area
Planned treatment with RT or chemoradiotherapy to a dose of ≥ 50 Gy Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1)
Disqualifiers
Gross macroscopic and/or microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
Prior RT to the head and neck including the oral or oropharyngeal mucosa
Prior cytotoxic chemotherapy in the last 3 months
Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
Trial design
Treatments tested in this trial
- photobiomodulation