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

NCT07697287 | Active Not Recruiting Phase 4

• 1 other identifier: 18414
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma; Oropharyngeal Cancers; Nasopharyngeal Cancer; Hypopharyngeal Cancer

Keywords

Radiation Therapy; Squamous Cell Carcinoma; Oral Cancer; Neck Cancer; Quality of Life (QoL)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Time to Grade 3 Oral Mucositis

  8 Weeks

• Patient Reported QoL

  8 Weeks

• Ability to Eat

  8 Weeks

• Time to the Initiation of Systemic Opiods

  8 Weeks

• Radiation Therapy Delay >7 Days

  8 Weeks

Study Arms (1)

Treatment Group: Gelclair

EXPERIMENTAL

Treatment Group: Patients who receive Gelclair as part of their participation in the study

Device: Gelclair Oral Mouth Rinse

Interventions

Gelclair Oral Mouth Rinse DEVICE

Gelclair is viscous gel that is designed to sooth pain relating to oral mucositis.

Treatment Group: Gelclair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Escarpment Cancer Research Institute (ECRI): collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Oropharyngeal Neoplasms; Nasopharyngeal Neoplasms; Hypopharyngeal Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort of Eligible Patients (Consecutive Recruitment)

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: July 13, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)