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NCT Number: NCT07697287

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Cancer Hypopharyngeal Neoplasms Mouth Diseases Mouth Neoplasms Nasopharyngeal Cancer Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oropharyngeal Cancers Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gelclair Oral Mouth Rinse

Device

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

Primary outcomes

  1. Feasibility of Recruitment:

    Time frame: 6 Months

    Feasibility based on:

    Recruitment Rate (Pass is successful recruitment of 40 patients within 6 months)

  2. Participant Compliance Rate

    Time frame: 8 weeks

    • Compliance Rate (Percent of patient who complete study & all questionnaires as per protocol, pass is >75%)

  3. Product Tolerability Rate

    Time frame: 8 Weeks

    • Tolerability Rate (Percent of patients who use Gelclair for 10 days or longer, pass is >50%)

Secondary outcomes

  1. Time to Grade 3 Oral Mucositis

    Time frame: 8 Weeks

    Time from enrollment (day 0 of RT) until grade 3 oral mucositis (measured in days) is reported.

  2. Patient Reported QoL

    Time frame: 8 Weeks

    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.

  3. Ability to Eat

    Time frame: 8 Weeks

    Number of days from start of treatment to feeding tube insertion / % participants requiring feeding tubes

  4. Time to the Initiation of Systemic Opiods

    Time frame: 8 Weeks

    Time from enrollment (day 0 of RT) until the initiation of potent systemic opioid or increase in dose from baseline (measured in days).

  5. Radiation Therapy Delay >7 Days

    Time frame: 8 Weeks

    Time from enrollment (day 0 of RT) until treatment delay of RT of 7 days or longer.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Escarpment Cancer Research Institute (ECRI)
  • Hamilton Health Sciences Corporation

Registry information

Official study title

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)

Acronym: TOPHAT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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