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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • photobiomodulation

Treatment groups

30 Participants
are divided into 1 treatment group