Intraoral Hypothermia Device for Preserving Taste During Radiation

NCT ID: NCT06579248

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2026-08-30

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.

Conditions

Head and Neck Cancer; Taste Dysfunction; Radiation Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intraoral Hypothermia Device

An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy.

Group Type: EXPERIMENTAL

Intraoral Device

Intervention Type: DEVICE

Device that circulates cooled water through the oral cavity.

Interventions

Intraoral Device

Device that circulates cooled water through the oral cavity.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Farzan Siddiqui

Senior Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Health System

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marissa Gilbert, BSBME

Role: CONTACT

mgilber6@hfhs.org

313-556-8422

Facility Contacts

Marissa Gilbert, BSBME

Role: primary

mgilber6@hfhs.org

313-556-8422

Other Identifiers

15529-01

Identifier Type: -

Identifier Source: org_study_id