Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis

Ottawa Hospital Research Institute

Status

Enrolling

Conditions

Mucositis Oral

Radiation Dermatitis

Head and Neck Cancer

Treatments

Device: Photobiomodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04671862

20190729-01H

Details and patient eligibility

About

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.

Full 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

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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