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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypopharyngeal Cancer; Nasopharyngeal Cancer; Squamous Cell Carcinoma; Oropharyngeal Cancers
• Intervention / Treatment: Device: Gelclair Oral Mouth Rinse

Detailed Description

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
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group: Gelclair; Treatment Group: Patients who receive Gelclair as part of their participation in the study	Device: Gelclair Oral Mouth Rinse; Gelclair is viscous gel that is designed to sooth pain relating to oral mucositis.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Grade 3 Oral Mucositis	Time from enrollment (day 0 of RT) until grade 3 oral mucositis (measured in days) is reported.	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.	8 Weeks
Ability to Eat	Number of days from start of treatment to feeding tube insertion / % participants requiring feeding tubes	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).	8 Weeks
Radiation Therapy Delay >7 Days	Time from enrollment (day 0 of RT) until treatment delay of RT of 7 days or longer.	8 Weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; Escarpment Cancer Research Institute (ECRI)

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 28, 2025
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Squamous Cell Carcinoma; Radiation Therapy; Oral Cancer; Neck Cancer; Quality of Life (QoL)
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Nasopharyngeal Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms
• Other Study ID Numbers: 18414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small scale feasibility trial that will inform if a larger, more impact trial is warranted. To protect patient privacy and confidentiality, IDE will not be shared outside of the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No