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.
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)
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)
Single group
photobiomodulation
Devicephotobiomodulation (low level laser therapy) application within and outside the oral cavity
Cumulative incidence and severity of acute oral mucositis
To describe the effect of PBM on the cumulative incidence and severity of acute OM as defined by the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) for radiation induced mucositis during RT and for 8 weeks following RT.
Function and quality of life (QoL)
Quantitative analysis of MD Anderson Symptom Inventory for Head and Neck Cancer scores to describe the effect of PBM on function and QoL
Pain in the oral cavity and throat
Quantitative analysis of Oral Mucositis Weekly Questionnaire-Head and Neck scores to describe effect of PBM on oral cavity and throat pain
Analgesia intake
Concurrent use of analgesic medications and mouthwashes to determine effect of PBM on need for analgesia (yes/no)
Need for enteral feeding
Use of enteral feeding to describe effect of PBM on ability to maintain oral intake
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