NCT04671862Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 18 Nov 2020
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Head and neck cancer
- NCT number
- NCT04671862
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 1 Jun 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the Head and Neck including the oral or oropharyngeal mucosa.
- Prior cytotoxic chemotherapy in the last 3 months
- Concurrent administration of Cetuximab
Other illness
- Gross macroscopic residual disease post surgery (R2 resection) or gross residual lymphadenopathy in the planned PBM treatment area
- Diagnosis of photosensitive disorder (cutaneous porphyria, xeroderma pigmentosum, etc)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.