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Clinical Trials in Australia / NCT07387978
Recruiting Not applicable

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

NCT07387978 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2025-11-26
Last updated
2026-02-04

Condition(s) studied

Oral Mucositis

Investigational drug(s) / intervention(s)

photobiomodulation

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)

Trial sites (1)

FacilityCityRegionStatus
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting

More Peter MacCallum Cancer Centre, Australia trials in Australia

Official registry record

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.

View NCT07387978 on ClinicalTrials.gov ↗ ← All trials in Australia