NCT06579248RecruitingEarly phase 1
Intraoral Hypothermia Device for Preserving Taste During Radiation
Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
Radiation therapy to the head and neck region is known to cause taste dysfunction. Preliminary studies showed that cooling normal structures may lower damage caused by radiation. The purpose of this research study is to see if it is feasible to use an intraoral cooling device during radiation treatments to preserve or lower the decline of taste function.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 23 Jul 2024
- Start date
- 12 Nov 2024
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Henry Ford Health System
- Diseases
- Head and neck cancer
- NCT number
- NCT06579248
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 15
- From 12 Nov 2024 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving other forms of therapy intended to reduce taste dysfunction.
- Patients who have received prior chemotherapy or radiation therapy for head and neck cancer.
- 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.
Other illness
- Patients with metastatic disease.
- Patient with allergies or hypersensitivity to materials in the intraoral bolus.
- 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 have tested positive for COVID-19 during the study period.
Other
- 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 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.