NCT07387978Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Dec 2025
- Start date
- 26 Nov 2025
- Primary completion date
- Nov 2028
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Diseases
- Head and neck cancer
- NCT number
- NCT07387978
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 26 Nov 2025 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior RT to the head and neck including the oral or oropharyngeal mucosa
- Prior cytotoxic chemotherapy in the last 3 months
- Concurrent administration of cetuximab
Other illness
- Gross macroscopic and/or microscopic residual disease post-surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
- Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
- Diagnosis of epilepsy
Other
- Known to be pregnant or planning to become pregnant within the trial period
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.