NCT07697287Active, not recruitingPhase 4
Oral Mucositis Management in Patients Receiving Radiation for Head and Neck Cancer: An Evaluation of a Barrier Based Treatment
A Prospective Feasibility Cohort Trial of Oral Mucositis Management in Patients Receiving Radiation for Head and Neck Cancer: An Evaluation of a Barrier-based Treatment (Gelclair)
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
Patients who are undergoing radiation therapy on their head and/or neck, are highly likely to experience oral mucositis, which is inflammation and irritation of the mucus membranes in your mouth. This inflammation leads to difficulty eating and drinking normally as it becomes painful to do so. Currently, the Juravinski Cancer Centre (JCC) uses a standard mouth rinse to try and help prevent inflammation/soothe the pain of inflammation caused by radiation treatments, however, better options may exist. Biosyent's Gelclair is a widely available, safe-to-use mouth rinse that aims to create a protective coating on your mucus membranes to help reduce inflammation and discomfort during your radiation treatment. We aim to see if this product provides a more positive experience for patients then the current mouth rinse utilized by the JCC.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 28 Aug 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- McMaster University
- Diseases
- Head and neck cancer
- NCT number
- NCT07697287
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 29
- From 15 Dec 2025 to the primary completion date, 30 Sept 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
- Plan to receive a concurrent chemotherapy agent other than cisplatin.
- Investigational agent of any kind within 30 days prior to enrollment.
- Concurrent administration of any other experimental intervention given for the purpose of preventing RIOM (see section 7.5).
Other illness
- History of allergies or hypersensitivity reactions to any of the components in Gelclair.
Other
- Patient is unable (i.e. insufficiently fluent) or unwilling to complete the weekly questionnaires which are written in English.
- Inability to provide informed consent.
- ECOG performance score 2 or better.
Who the study is looking for
- 18 years of age or older.
- Histologically proven (from either the primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx or oral cavity.
- Plan to receive at least 60 Gy dose of radiotherapy to be delivered daily Monday to Friday for 6 to 7 weeks.
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 |
|---|---|---|---|
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.