Oral Mucositis Management in Patients Receiving Radiation for Head and Neck Cancer: An Evaluation of a Barrier Based Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Gelclair Oral Mouth Rinse: Gelclair is viscous gel that is designed to sooth pain relating to oral mucositis.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Feasibility of Recruitment: — 6 Months
  Feasibility based on: Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months)
• Participant Compliance Rate — 8 weeks
  • Compliance Rate (Percent of patient who complete study \& all questionnaires as per protocol, pass is \>75%)
• Product Tolerability Rate — 8 Weeks
  • Tolerability Rate (Percent of patients who use Gelclair for 10 days or longer, pass is \>50%)

Trial sites (1)

More McMaster University trials in Canada