Low-level laser (photobiomodulation) to prevent mouth sores during radiotherapy for oral cancer

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

This study will try low-level laser therapy (photobiomodulation), given five times a week during radiotherapy, to reduce mouth sores in adults treated for oral cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peter MacCallum Cancer Centre, Australia (other)
• Drugs / interventions: cetuximab, chemotherapy
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07387978 on ClinicalTrials.gov

What this trial studies

This single-center interventional study enrolls post-operative oral cavity cancer patients with clear margins who are scheduled for radiotherapy of ≥50 Gy, with or without chemotherapy. Participants will receive photobiomodulation using a THOR laser five times per week concurrent with their radiotherapy course. The trial will record incidence and severity of oral mucositis, pain levels, quality of life, analgesia needs, oral intake, trismus severity, and hospitalization rates. PBM is supported by prior literature and guideline recommendations and the device used has local regulatory approval.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed oral cavity cancer after surgery with clear margins (R0/R1), ECOG 0–1, intact oral mucosa, and planned radiotherapy ≥50 Gy with or without chemotherapy.

Not a fit: Patients with gross residual disease after surgery (R2), prior head and neck radiotherapy, recent cytotoxic chemotherapy, photosensitive disorders, existing oral ulceration, or poor performance status are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, photobiomodulation could reduce how often and how severely mouth sores occur, lower pain and hospital admissions, and help patients maintain oral intake during radiotherapy.

How similar studies have performed: Multiple randomized trials and meta-analyses have shown PBM can prevent or reduce oral mucositis in head and neck cancer, and PBM is recommended in MASCC and NICE guidelines with device approval in Australia.

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

Where this trial is running

Melbourne, Victoria

• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Sophie Beaumont, Bachelor of Dental surgery

Conditions: Oral Mucositis, photobiomodulation, low level laser therapy, head and neck cancer, oral cancer, radiotherapy, oral mucositis