Intraoral Hypothermia Device for Preserving Taste During Radiation

This study is testing an Intraoral Device, which circulates cooled water in your mouth, to see if it can help preserve your sense of taste during radiation therapy for head and neck cancer. Radiation often causes taste problems, and earlier research suggests cooling might reduce damage. This study aims to find out if using this device during radiation treatments can prevent or lessen the decline in taste. You may be able to join if you are at least 18 years old, have locally advanced squamous cell carcinoma of the larynx, and are receiving both radiation and chemotherapy. The main goal is to measure changes in your taste at 6 months after your radiation treatment ends. The study plans to enroll 15 participants, but its current status is unclear.

Study design: This is an interventional study planning to enroll 15 participants. It is not specified if it is randomized or blinded.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your taste will be measured at 6 months after your radiation treatment is completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Intraoral Hypothermia Device for Preserving Taste During Radiation

Recruiting

EARLY_PHASE1Ages 18+Interventional

Henry Ford Health System

~15 participants

Updated 2026-01-14 on ClinicalTrials.gov

What's tested:Intraoral Device

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in Dysgeusia

Measured over 6 months after RT completion

Conditions

Head and Neck Cancer

Taste Dysfunction

Radiation Therapy

NCT06579248

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Henry Ford Health System
Detroit, Michiganstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Marissa Gilbert, BSBME

[email protected]

313-556-8422

Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Change in Dysgeusia6 months after RT completion
Taste will be measured objectively using Burghart taste strips in five different concentrations of salty, sweet, sour, bitter, and umami. Taste will be assessed on a yes/no scale to reflect the ability to correctly identify taste category. Taste will be measured subjectively with a series of previously-validated, patient-reported taste-related questions. The questions comprise of a modified Chemotherapy-induced Taste Alteration Scale (CiTAS), one question from the Head and Neck Quality of Life questionnaire (HNQOL, question 2H) and one question from the University of Washington Head and Neck-specific Quality of Life questionnaire (UWQOL, question 9). The CiTAS uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste. The HNQOL uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste. The UWQOL uses a scale of 1-4, with 1 meaning taste is normal and 4 being unable to taste. Questionnaires are used together to quantify change in taste.

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