Clinical trial NCT06579248: Intraoral Hypothermia Device for Preserving Taste During Radiation
Official title: Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Taste Dysfunction
Radiation Therapy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Dysgeusia
timeFrame: 6 months after RT completion
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References: