Intraoral Hypothermia Device for Preserving Taste During Radiation

Trial Title: Intraoral Hypothermia Device for Preserving Taste During Radiation

NCT ID: NCT06579248

Condition: Head and Neck Cancer
Taste Dysfunction
Radiation Therapy

Conditions: Official terms:
Taste Disorders
Hypothermia

Study type: Interventional

Study phase: Early Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Intraoral Device
Description: Device that circulates cooled water through the oral cavity.
Arm group label: Intraoral Hypothermia Device

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Henry Ford Health System

Address:
City: Detroit
Zip: 48202-2689
Country: United States

Start date: October 30, 2024

Completion date: August 30, 2025

Lead sponsor:
Agency: Henry Ford Health System
Agency class: Other

Source: Henry Ford Health System

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06579248