Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

NCT ID: NCT04671862

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-12-31

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

Conditions

Mucositis Oral; Head and Neck Cancer; Radiation Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Photobiomodulation

Parameters: combined 633nm and 870 nm @1000mW

• 1 Treatment pre radiotherapy
• 3 treatments weekly during radiotherapy

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ottawa Health Sciences Research Ethics Board

Role: CONTACT

REBAdministration@toh.ca

613-798-5555 ext. 16719

Facility Contacts

Marc Gaudet, MD MSc MHA

Role: primary

mgaudet@toh.ca

613-737-7700 ext. 70206

Kristopher Dennis, MD PhD

Role: backup

krdennis@toh.ca

613-737-7700 ext. 70206

Other Identifiers

20190729-01H

Identifier Type: -

Identifier Source: org_study_id