A Study to Describe the Effect of Photobiomodulation (Low Level Laser Therapy) in Reducing the Severity and Incidence of Oral Mucositis (Oral Ulceration) in Oral Cancer Patients Undergoing Radiation Treatment
photobiomodulation: photobiomodulation (low level laser therapy) application within and outside the oral cavity
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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)
* Intact oral mucosa (no visible ulceration, dehiscence, or active infection)
Exclusion Criteria:
* 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)
* Concurrent administration of cetuximab
* Known to be pregnant or planning to become pregnant within the trial period
* Diagnosis of epilepsy
Primary outcome measure(s)
Cumulative incidence and severity of acute oral mucositis — Through study completion, an average of 1 year 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.
Trial sites (1)
Facility
City
Region
Status
Peter MacCallum Cancer Centre
Melbourne
Victoria
Recruiting
More Peter MacCallum Cancer Centre, Australia trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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