NCT07387978

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

BACKGROUND: Strong evidence exists within the literature regarding the effectiveness and safety of PBM in preventing oral mucositis in head and neck cancer patients. PBM is recommended in the Multinational Association of Supportive Care in Cancer and National Institute of Health and Care Excellence oral mucositis prevention guidelines, as a treatment modality for oral mucositis prevention in H\&N cancer patients. PBM using the THOR laser has received TGA approval for use in prevention and treatment of oral mucositis in Australia. PARTICIPANTS: post operative oral cancer patients, with clear margins, planned for radiotherapy (50Gy or greater) +/- chemotherapy. METHODS: participants will receive PBM treatment five times a week throughout the course of their radiotherapy. EXPECTED OUTCOMES: decrease in incidence and severity of oral mucositis, decrease in pain levels and improved quality of life, less need for analgesia, increased ability to maintain oral intake, less severe trismus, lower rates of hospitalization

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DEVICE	photobiomodulation	photobiomodulation (low level laser therapy) application within and outside the oral cavity

Timeline

• Start date: 2025-11-26
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study