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Chill your mouth, save your taste? new device tested during cancer radiation

NCT ID NCT06579248

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a cooling device placed inside the mouth during radiation therapy for larynx cancer. The goal is to see if cooling can protect taste buds from radiation damage and prevent loss of taste. About 15 adults with advanced larynx cancer will try the device and report their taste changes.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Aug 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: * Patients being treated with combination radiation therapy and chemotherapy (definitive) for locally advanced (AJCC 8th cT3-4 or cN+) squamous cell carcinoma of the larynx. * Age ≥ 18. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Patients will engage in the informed consent process and provide study-specific informed consent prior to study entry and must be able to fill out toxicity and quality of life related questionnaires. * Patients should be concurrently treated with any of the following chemotherapy drugs: cisplatin, carboplatin, and cetuximab. Exclusion Criteria: * Patients receiving other forms of therapy intended to reduce taste dysfunction. * Patients with metastatic disease. * Patient with allergies or hypersensitivity to materials in the intraoral bolus. * Patients who have received prior chemotherapy or radiation therapy for head and neck cancer. * Patients who decline to use or cannot tolerate the intraoral device. * Patients who are current or recent (within 3 months of treatment initiation) cigarette smokers. * Patients who are unable to complete the required forms; however, verbal completion is adequate if recorded on the form daily. * Patients with uncontrolled serious illness including, but not limited to, ongoing or serious active infection requiring IV antibiotics for over 30 days, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than chronic, stable atrial fibrillation, immunocompromised state, significant hepatic insufficiency, significant hematological disease, and any serious or unstable psychological condition. * Patients who are on any of the following medication that cannot find a suitable substitute during the study period: acetazolamide, maribavir (TAK-620, Phase 3 trial drug), eszopiclone, topiramate, captopril, lithium, procainamide, terbinafine, and amiodarone. * Patients who have taste loss at baseline, assessed subjectively and objectively at the first encounter, will be excluded from the study and all analysis. They will be replaced with a new patient. * Patients who have tested positive for COVID-19 during the study period.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms laryngeal squamous cell carcinoma Taste Disorders

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202-2689, United States

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