Actively Recruiting
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
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2026-02-04
30
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has provided written informed consent using the PBM PICF
- Age 18 years or older at screening
- Histological diagnosis of head and neck cancer of the oral cavity with no macroscopic or microscopic residual disease after surgery (R0 or R1 resection) confirmed by pathology
- Planned treatment with radiotherapy or chemoradiotherapy to a dose of 50 Gy or greater
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Intact oral mucosa with no visible ulcers, dehiscence, or active infection
You will not qualify if you...
- Presence of gross residual disease after surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
- Prior radiotherapy to the head and neck including oral or oropharyngeal mucosa
- Received cytotoxic chemotherapy in the last 3 months
- Diagnosis of photosensitive disorders such as cutaneous porphyria or xeroderma pigmentosum
- Concurrent treatment with cetuximab
- Known pregnancy or planning pregnancy during the trial period
- Diagnosis of epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
S
Sophie Beaumont, Bachelor of Dental surgery
CONTACT
S
Shae Beaton, Bachelor of oral health
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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