Mucositis OralNCT04671862
Photobiomodulation for the Prevention of Radiation Induced Oral Mucositis
A study testing Photobiomodulation in people with Mucositis Oral and Head and Neck Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucositis Oral, Head and Neck Cancer, Radiation Dermatitis
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Photobiomodulation
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Parameters: combined 633nm and 870 nm @1000mW
* 1 Treatment pre radiotherapy
* 3 treatments weekly during radiotherapy Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurence of radiation mucositis
CTCAE version 2.0
Measured: 7-14 days post radiotherapy
Rate of occurence of radiation mucositis
CTCAE version 2.0
Measured: 1 month post radiotherapy
Rate of occurence of radiation mucositis
CTCAE version 2.0
Measured: 3 months post radiotherapy
Rate of occurence of radiation mucositis
CTCAE version 2.0
Measured: 6 months post radiotherapy
Rate of occurence of radiation mucositis
CTCAE version 2.0
Measured: 12 months post radiotherapy
Rate of occurence of radiation mucositis
CTCAE version 2.0
Measured: 24 months post radiotherapy
Secondary outcomes (23)
Brief Pain Inventory
Pain questionnaire
Measured: 7-14 days post radiotherapy
Brief Pain Inventory
Pain questionnaire
Measured: 1 month post radiotherapy
Brief Pain Inventory
Pain questionnaire
Measured: 3 months post radiotherapy
Brief Pain Inventory
Pain questionnaire
Measured: 6 months post radiotherapy
Brief Pain Inventory
Pain questionnaire
Measured: 12 months post radiotherapy
Brief Pain Inventory
Pain questionnaire
Measured: 24 months post radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Swallowing related quality of life
Measured: 7-14 days post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Swallowing related quality of life
Measured: 1 month post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Swallowing related quality of life
Measured: 3 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Swallowing related quality of life
Measured: 12 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Swallowing related quality of life
Measured: 24 months post-radiotherapy
EQ-5D
General Quality of life questionnaire
Measured: 7-14 days post radiotherapy
EQ-5D
General Quality of life questionnaire
Measured: 1 month post radiotherapy
EQ-5D
General Quality of life questionnaire
Measured: 3 months post radiotherapy
EQ-5D
General Quality of life questionnaire
Measured: 6 months post radiotherapy
EQ-5D
General Quality of life questionnaire
Measured: 12 months post radiotherapy
EQ-5D
General Quality of life questionnaire
Measured: 24 months post radiotherapy
Radiation dermatitis
CTCAE version 5.0
Measured: 7-14 days post radiotherapy
Radiation dermatitis
CTCAE version 5.0
Measured: 1 month post radiotherapy
Radiation dermatitis
CTCAE version 5.0
Measured: 3 months post radiotherapy
Radiation dermatitis
CTCAE version 5.0
Measured: 6 months post radiotherapy
Radiation dermatitis
CTCAE version 5.0
Measured: 12 months post radiotherapy
Radiation dermatitis
CTCAE version 5.0
Measured: 24 months post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671862
- Sponsor's protocol ID
- 20190729-01H
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for the Prevention of Oral Mucositis in Patients Treated With Radiotherapy for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04671862
- Acronym / sponsor ID
- 20190729-01H
- Conditions
- Mucositis Oral, Head and Neck Cancer, Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: PhotobiomodulationParameters: combined 633nm and 870 nm @1000mW * 1 Treatment pre radiotherapy * 3 treatments weekly during radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationParameters: 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) | Device | Photobiomodulation |
Primary outcome
Rate of occurence of radiation mucositis
Time frame: 7-14 days post radiotherapy
CTCAE version 2.0
Rate of occurence of radiation mucositis
Time frame: 1 month post radiotherapy
CTCAE version 2.0
Rate of occurence of radiation mucositis
Time frame: 3 months post radiotherapy
CTCAE version 2.0
Rate of occurence of radiation mucositis
Time frame: 6 months post radiotherapy
CTCAE version 2.0
Rate of occurence of radiation mucositis
Time frame: 12 months post radiotherapy
CTCAE version 2.0
Rate of occurence of radiation mucositis
Time frame: 24 months post radiotherapy
CTCAE version 2.0
23 secondary outcomes
Brief Pain Inventory
Time frame: 7-14 days post radiotherapy
Brief Pain Inventory
Time frame: 1 month post radiotherapy
Brief Pain Inventory
Time frame: 3 months post radiotherapy
Brief Pain Inventory
Time frame: 6 months post radiotherapy
Brief Pain Inventory
Time frame: 12 months post radiotherapy
Brief Pain Inventory
Time frame: 24 months post radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Time frame: 7-14 days post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Time frame: 1 month post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Time frame: 3 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Time frame: 12 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN)
Time frame: 24 months post-radiotherapy
EQ-5D
Time frame: 7-14 days post radiotherapy
EQ-5D
Time frame: 1 month post radiotherapy
EQ-5D
Time frame: 3 months post radiotherapy
EQ-5D
Time frame: 6 months post radiotherapy
EQ-5D
Time frame: 12 months post radiotherapy
EQ-5D
Time frame: 24 months post radiotherapy
Radiation dermatitis
Time frame: 7-14 days post radiotherapy
Radiation dermatitis
Time frame: 1 month post radiotherapy
Radiation dermatitis
Time frame: 3 months post radiotherapy
Radiation dermatitis
Time frame: 6 months post radiotherapy
Radiation dermatitis
Time frame: 12 months post radiotherapy
Radiation dermatitis
Time frame: 24 months post radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Mucositis Oral and Head and Neck Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occurence of radiation mucositis (time frame: 7-14 days post radiotherapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.