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

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 | DecenTrialz