Status:
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
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 +/- chemother...
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 Multinat...
Eligibility Criteria
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
Key Trial Info
Start Date :
November 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07387978
Start Date
November 26 2025
End Date
November 1 2028
Last Update
February 4 2026
Active Locations (1)
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1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000