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Mouth rinse could ease painful radiation side effects for head and neck cancer patients

NCT ID NCT07697287

Symptom relief Sponsor: McMaster University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial tests Gelclair, a mouth rinse that forms a protective coating over the mouth's lining, to see if it eases the painful mouth sores (oral mucositis) caused by radiation therapy for head and neck cancer. The study enrolls adults with squamous cell carcinoma who will receive at least 60 Gy of radiation over 6-7 weeks. Researchers will measure how well patients tolerate the rinse and whether it improves their quality of life compared to the standard rinse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gelclair (oral mouth rinse)
What this could lead to
If effective, Gelclair could offer a simple, safe way to reduce mouth pain during radiation, making eating and drinking easier for patients.
What could go wrong
This is a small feasibility study, not a large trial. It may not prove Gelclair works better than standard rinses, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

29 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms hypopharyngeal carcinoma hypopharynx cancer Mouth Neoplasms nasopharyngeal carcinoma, susceptibility to, 1 nasopharyngeal neoplasm oral cavity squamous cell carcinoma oropharynx cancer oropharynx squamous cell carcinoma squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypopharyngeal cancer Nasopharyngeal cancer Oropharyngeal cancers Squamous cell carcinoma

Contacts and locations

Locations

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

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