Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiation Dermatitis; Mucositis Oral
• Intervention / Treatment: Device: Photobiomodulation

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

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ottawa Health Sciences Research Ethics Board; Phone Number: 16719 613-798-5555; Email: REBAdministration@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Contact: Marc Gaudet, MD MSc MHA; Phone Number: 70206 613-737-7700; Email: mgaudet@toh.ca
      • Contact: Kristopher Dennis, MD PhD; Phone Number: 70206 613-737-7700; Email: krdennis@toh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation; Parameters: combined 633nm and 870 nm @1000mW; 1 Treatment pre radiotherapy; 3 treatments weekly during radiotherapy	Device: Photobiomodulation; 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)

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Radiation Injuries; Head and Neck Neoplasms; Dermatitis; Mucositis; Radiodermatitis; Stomatitis
• Other Study ID Numbers: 20190729-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No