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 (PBM)

Peter MacCallum Cancer Centre, Australia

Status: Enrolling

Conditions: Oral Mucositis

Treatments: Device: photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07387978

25/131

Details and patient eligibility

About

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.

Full 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 Multinational Association of Supportive Care in Cancer and National Institute of Health and Care Excellence oral mucositis prevention guidelines, as a treatment modality for oral mucositis prevention in H&N cancer patients. PBM using the THOR laser has received TGA approval for use in prevention and treatment of oral mucositis in Australia.

PARTICIPANTS: post operative oral cancer patients, with clear margins, planned for radiotherapy (50Gy or greater) +/- chemotherapy.

METHODS: participants will receive PBM treatment five times a week throughout the course of their radiotherapy.

EXPECTED OUTCOMES: decrease in incidence and severity of oral mucositis, decrease in pain levels and improved quality of life, less need for analgesia, increased ability to maintain oral intake, less severe trismus, lower rates of hospitalization

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Photobiomodulation

Experimental group

Description:

Participants will receive photobiomodulation therapy five times a week during the course of their radiation treatment. Upon completion of radiotherapy, if oral mucositis is still present, participants can choose to continue photobiomodulation treatment until oral mucositis has resolved. The frequency of photobiomodulation will be conducted at the discretion of the investigator.

Treatment:

Device: photobiomodulation