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Squamous Cell CarcinomaPhase 4TOPHATNCT07697287

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

A Phase 4 study testing Gelclair Oral Mouth Rinse in people with Squamous Cell Carcinoma and Oropharyngeal Cancers, run by McMaster University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gelclair Oral Mouth Rinse
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteCanada
Study dates
15 Dec 2025to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

Other trials in Canada

About this study

Official 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)

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.

Read the 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.

Being tested
Gelclair Oral Mouth Rinse
Keywords
Radiation Therapy, Squamous Cell Carcinoma, Oral Cancer, Neck Cancer, Quality of Life (QoL)
Medical subject headings
Carcinoma, Squamous Cell, Oropharyngeal Neoplasms, Nasopharyngeal Neoplasms, Hypopharyngeal Neoplasms, Mouth Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gelclair Oral Mouth RinseDevice

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

Study groups in NCT07697287
Study groupRoleWhat they receive
Treatment Group: GelclairExperimentalTreatment Group: Patients who receive Gelclair as part of their participation in the study
Receives: Device: Gelclair Oral Mouth Rinse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment:

    Feasibility based on:

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

    Measured: 6 Months

  2. Participant Compliance Rate

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

    Measured: 8 weeks

  3. Product Tolerability Rate

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

    Measured: 8 Weeks

Secondary outcomes (5)

  1. Time to Grade 3 Oral Mucositis

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

    Measured: 8 Weeks

  2. 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.

    Measured: 8 Weeks

  3. Ability to Eat

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

    Measured: 8 Weeks

  4. 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).

    Measured: 8 Weeks

  5. Radiation Therapy Delay >7 Days

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

    Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start15 Dec 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort of Eligible Patients (Consecutive Recruitment)
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697287
Sponsor's protocol ID
18414
Acronym
TOPHAT
Status last verified
Jul 2026
First submitted
28 Aug 2025
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gelclair Oral Mouth Rinse in people with Squamous Cell Carcinoma and Oropharyngeal Cancers, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment: (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07697287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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