Oral Mucositis Management in Patients Receiving Radiation for Head and Neck Cancer: An Evaluation of a Barrier Based Treatment (NCT07697287)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: Juravinski Cancer Centre — Hamilton, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
- 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).
- History of allergies or hypersensitivity reactions to any of the components in Gelclair.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Juravinski Cancer Centre — Hamilton, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.