Oral Mucositis
Conditions
Keywords
photobiomodulation, low level laser therapy, head and neck cancer, oral cancer, radiotherapy, oral mucositis
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 +/- 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.
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 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
Interventions
DEVICEphotobiomodulation
photobiomodulation (low level laser therapy) application within and outside the oral cavity
Sponsors
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence and severity of acute oral mucositis | Through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function and quality of life (QoL) | Through study completion, an average of 1 year | Quantitative analysis of MD Anderson Symptom Inventory for Head and Neck Cancer scores to describe the effect of PBM on function and QoL |
| Pain in the oral cavity and throat | Through study completion, an average of 1 year | Quantitative analysis of Oral Mucositis Weekly Questionnaire-Head and Neck scores to describe effect of PBM on oral cavity and throat pain |
| Analgesia intake | Through study completion, an average of 1 year | Concurrent use of analgesic medications and mouthwashes to determine effect of PBM on need for analgesia (yes/no) |
| Need for enteral feeding | Through study completion, an average of 1 year | Use of enteral feeding to describe effect of PBM on ability to maintain oral intake |
| Hospitalisation rates | Through study completion, an average of 1 year | Hospitalisation rates due to mucositis in the oral cavity or related events will be documented |
| Trismus | Through study completion, an average of 1 year | Maximal-interincisal opening. For participants who are edentulous, the distance from the edentulous ridge to the opposing side vertically will be used instead |
Countries
Australia
Contacts
CONTACTSophie Beaumont, Bachelor of Dental surgery
CONTACTShae Beaton, Bachelor of oral health
Outcome results
None listed