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

Peter MacCallum Cancer Centre, Australia30 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Oral Mucositis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cumulative incidence and severity of acute oral mucositis

To describe the effect of PBM on the cumulative incidence and severity of acute OM as defined by the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) for radiation induced mucositis during RT and for 8 weeks following RT.