RecruitingNot ApplicableNCT07387978

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

A Pilot Study to Describe the Effect of Photobiomodulation in Reducing the Severity and Incidence of Oral Mucositis in Oral Cancer Patients Undergoing Radiation Treatment


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

30 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether low-level laser therapy (photobiomodulation or PBM) — a painless light treatment applied to the inside of the mouth — can prevent or reduce oral mucositis (painful mouth sores) in patients with oral cavity cancer who are undergoing radiation therapy. Mouth sores are a common and debilitating side effect of head and neck radiation. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with oral cavity cancer and had surgery that removed all visible cancer (R0 or R1 resection) - You are scheduled to receive radiation therapy or chemoradiotherapy to a dose of at least 50 Gy - You have good performance status (ECOG 0 or 1) - Your mouth lining is intact with no current sores or infection **You may NOT be eligible if...** - There is residual cancer left after surgery (R2 resection) - You have had prior radiation to the head or neck area - You had chemotherapy in the last 3 months - You have epilepsy or a photosensitive disorder (such as porphyria) - You are currently receiving cetuximab (another cancer drug) - You are pregnant or planning to become pregnant during the trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEphotobiomodulation

photobiomodulation (low level laser therapy) application within and outside the oral cavity


Locations(1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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NCT07387978


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