Chill your mouth, save your taste? new device tested during cancer radiation
NCT ID NCT06579248
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Henry Ford Health System
RECRUITINGDetroit, Michigan, 48202-2689, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Glowing dye lights up throat tumors during surgery
- Can precision radiation and immunotherapy team up against abdominal colorectal cancer?