A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer

The goal of this clinical trial is to learn if Gelclair lubricant gel can help manage Oral Mucositis (OM) among Oropharyngeal and Oral cavity cancer patients receiving radiation treatment. The main questions it aims to answer are: 1. Does Gelclair help to manage the symptoms of OM and decrease its severity? 2. What do participants report as the maximum levels of pain and difficulties with swallowing? Researchers will compare Gelclair to the standard of care mouthwash treatment for OM (currently used for all patients with symptomatic OM) to see if Gelclair is helpful in managing oral mucositis. For the cohort using Gelclair, participants will: 1. Take the prescribed treatment for OM (Gelclair or Oncology mouthwash) once it is diagnosed, up to and including 4 weeks after radiation completes. 2. Complete a weekly survey about their OM symptoms up to and including 4 weeks after radiation completes. 2\. Report any problems experienced with prescribed treatment for OM (Gelclair or mouthwash). The same data will be collected for the cohort using standard of care mouthwash for comparison.

NCT Number	NCT06897215
Lead Sponsor	Nova Scotia Health Authority
Conditions	Oral Mucositis Due to Radiation
Enrollment	48 participants
Start Date	2025-05-01
Primary Completion	2025-11-30 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-09