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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Sophie Beaumont, Bachelor of Dental surgery
• Email: sophie.beaumont@petermac.org
• Phone: 03 85596443

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.