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A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer
Sponsor: Nova Scotia Health Authority
Summary
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.
Official title: A Sequential Cohort Study Exploring Gelclair in the Management of Oral Mucostitis (OM) in Patients Receiving Radical Radiation for Head and Neck Cancer (GOMS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-05-01
Completion Date
2025-12-31
Last Updated
2025-04-09
Healthy Volunteers
No
Conditions
Interventions
Hyaluronic acid hydrogel
Assigned to the Experimental Cohort once OM grade 2.0 presents, Gelclair is a hyaluronic acid hydrogel that acts as a protective film in the management of OM. This product is used internationally and has been recently approved by Health Canada as a Class 2 Medical Device with an indication to manage the symptoms of OM caused by radiotherapy and chemotherapy.