Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

Study Overview
=================
Brief Summary
-----------------
Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context.

Detailed Description
-----------------
Introduction: Radiotherapy for head and neck cancer can cause severe mucositis (ulcers in the mouth) and pain. Photobiomodulation (Light therapy) will be used before and during radiotherapy to try to reduce the occurence and severity of mucositis in patients treated with radiotherapy for head and neck cancer Rationale: Previous studies in head and neck cancer patients have shown that photobiomodulation (light therapy) can prevent mucositis. There are currently no centers in Canada using this technique in routine practice, but this is recommended in International guidelines and widely used in Europe. The investigators therefore wish to implement this technique in Ottawa under the umbrella of a clinical trial to insure its safety and efficacy in a Canadian context. Purpose/Objectives: Primary Objective Primary Objective • To determine the cumulative incidence of acute mucositis as defined by CTCAE version 2.0 for radiation induced mucositis (Appendix 1) during radiotherapy and for 1month following radiotherapy Secondary Objectives To determine the following during radiotherapy and for 24 months post-treatment Rate of occurrence of acute radiation dermatitis Pain scores Opioid use ESAS scores during and after RT FACT-HN questionnaire scores Late subcutaneous neck fibrosis Late mucosal and skin telangiectasia Study design/methodology: This is single arm prospective cohort study of a single intervention (photobiomodulation) in patients with head and neck cancer for the prevention of oral mucositis. Outcomes will be the following: Rates of acute and late mucositis according to CTCAE version 2.0 Rates of acute and late dermatitis and fibrosis according to CTCAE version 5.0 Rates of late teleangiectasia Pain scores as per Edmonton Symptom assessment scale (ESAS) and modified brief pain inventory Rates of opioid use FACT-HN scores EQ5D scores Anticipated public/scientific benefit: This study aims to study the use of Photobiomodulation treatments for prevention of oral mucositis. This is recommended in international guidelines but not used in routine practice in Canada. The benefit of this study is to allow implemetation of this technique in the Canadian context in a controlled and evaluated manner. This will hopefully then allow further study and wider implementation of this technique both in Ottawa and in Canada

Official Title
-----------------
Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer

Conditions
-----------------
Mucositis Oral, Head and Neck Cancer, Radiation Dermatitis

Intervention / Treatment
-----------------
* Device: Photobiomodulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years of age Willing and able to understand and sign informed consent form approved by the institutional review board (IRB) Histological diagnosis of head and neck cancer of the oral cavity with no evidence of macroscopic residual disease post-surgery (R0 or R1 resection) and no gross residual lymphadenopathy in the planned PBM treatment area Planned treatment with radiotherapy or chemoradiotherapy to a dose of ≥ 50 Gy ECOG Performance Status of 0 or 1 Intact oral mucosa (no visible ulceration, dehiscence or active infection Exclusion Criteria: Gross macroscopic residual disease post surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area Prior radiotherapy 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation<br>Parameters: combined 633nm and 870 nm @1000mW 1 Treatment pre radiotherapy 3 treatments weekly during radiotherapy | Device: Photobiomodulation<br>* Parameters: combined 633nm and 870 nm @1000mW 1 Treatment 4J continuous prior to RT. (Within 14 days of RT start) 3 treatments weekly during RT (6 J at 12 Hz, 80% duty cycle)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of occurence of radiation mucositis | CTCAE version 2.0 | 7-14 days post radiotherapy | 
| Rate of occurence of radiation mucositis | CTCAE version 2.0 | 1 month post radiotherapy | 
| Rate of occurence of radiation mucositis | CTCAE version 2.0 | 3 months post radiotherapy | 
| Rate of occurence of radiation mucositis | CTCAE version 2.0 | 6 months post radiotherapy | 
| Rate of occurence of radiation mucositis | CTCAE version 2.0 | 12 months post radiotherapy | 
| Rate of occurence of radiation mucositis | CTCAE version 2.0 | 24 months post radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | Pain questionnaire | 7-14 days post radiotherapy | 
| Brief Pain Inventory | Pain questionnaire | 1 month post radiotherapy | 
| Brief Pain Inventory | Pain questionnaire | 3 months post radiotherapy | 
| Brief Pain Inventory | Pain questionnaire | 6 months post radiotherapy | 
| Brief Pain Inventory | Pain questionnaire | 12 months post radiotherapy | 
| Brief Pain Inventory | Pain questionnaire | 24 months post radiotherapy | 
| Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 7-14 days post-radiotherapy | 
| Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 1 month post-radiotherapy | 
| Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 3 months post-radiotherapy | 
| Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 12 months post-radiotherapy | 
| Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) | Swallowing related quality of life | 24 months post-radiotherapy | 
| EQ-5D | General Quality of life questionnaire | 7-14 days post radiotherapy | 
| EQ-5D | General Quality of life questionnaire | 1 month post radiotherapy | 
| EQ-5D | General Quality of life questionnaire | 3 months post radiotherapy | 
| EQ-5D | General Quality of life questionnaire | 6 months post radiotherapy | 
| EQ-5D | General Quality of life questionnaire | 12 months post radiotherapy | 
| EQ-5D | General Quality of life questionnaire | 24 months post radiotherapy | 
| Radiation dermatitis | CTCAE version 5.0 | 7-14 days post radiotherapy | 
| Radiation dermatitis | CTCAE version 5.0 | 1 month post radiotherapy | 
| Radiation dermatitis | CTCAE version 5.0 | 3 months post radiotherapy | 
| Radiation dermatitis | CTCAE version 5.0 | 6 months post radiotherapy | 
| Radiation dermatitis | CTCAE version 5.0 | 12 months post radiotherapy | 
| Radiation dermatitis | CTCAE version 5.0 | 24 months post radiotherapy |