Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Oropharyngeal Cancers | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gelclair Oral Mouth Rinse | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group: Gelclair
- description
- Treatment Group: Patients who receive Gelclair as part of their participation in the study
- interventionNames
- Device: Gelclair Oral Mouth Rinse
Primary outcomes (3)
- measure
- Feasibility of Recruitment:
- timeFrame
- 6 Months
- description
- Feasibility based on: Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months)
- measure
- Participant Compliance Rate
- timeFrame
- 8 weeks
- description
- • Compliance Rate (Percent of patient who complete study \& all questionnaires as per protocol, pass is \>75%)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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.
References
Publications (0)
Data not yet available