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.
The current magic mouthwash being utilized at the JCC for standard of care for Heck and Neck Radiation patients has been shown to not be anymore effective than other standard sulcate-tantum mouthwashes in preventing discomfort or reducing the requirement of needing a feeding tube for sustenance during radiation treatments. More recently two mucoadhesive topical coating agents have been approved in Canada for this population of patients, Gengigel and Gelclair. These agents adhere to the mucosa and potentially improve efficacy of the therapeutic agent due to rapid absorption and easy application. A recent systematic review of bioadhesives for the treatment of RIOM found statistically significant decrease in severe oral mucositis. We aim to determine if patients tolerate gelclair use, and to determine their use of and satisfaction with gelclair. This will inform the need for a large national RCT on Gelclair use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
29
Gelclair is viscous gel that is designed to sooth pain relating to oral mucositis.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Feasibility of Recruitment:
Feasibility based on: Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months)
Time frame: 6 Months
Participant Compliance Rate
• Compliance Rate (Percent of patient who complete study \& all questionnaires as per protocol, pass is \>75%)
Time frame: 8 weeks
Product Tolerability Rate
• Tolerability Rate (Percent of patients who use Gelclair for 10 days or longer, pass is \>50%)
Time frame: 8 Weeks
Time to Grade 3 Oral Mucositis
Time from enrollment (day 0 of RT) until grade 3 oral mucositis (measured in days) is reported.
Time frame: 8 Weeks
Patient Reported QoL
The severity of patient-reported symptoms of oral mucositis throughout the course of treatment as determined by clinically significant change in Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN; see Appendix II questions 1-8) scores from baseline. The OMWQ-HN will be administered before the start of RT at baseline, and every 2 weeks until completion of RT, therefore weeks 2, 4, and 6 and then 1 final time 2 weeks post-treatment on week 8.
Time frame: 8 Weeks
Ability to Eat
Number of days from start of treatment to feeding tube insertion / % participants requiring feeding tubes
Time frame: 8 Weeks
Time to the Initiation of Systemic Opiods
Time from enrollment (day 0 of RT) until the initiation of potent systemic opioid or increase in dose from baseline (measured in days).
Time frame: 8 Weeks
Radiation Therapy Delay >7 Days
Time from enrollment (day 0 of RT) until treatment delay of RT of 7 days or longer.
Time frame: 8 Weeks
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