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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiation Therapy; Taste Dysfunction
• Intervention / Treatment: Device: Intraoral Device

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Marissa Gilbert, BSBME; Phone Number: 313-556-8422; Email: mgilber6@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202-2689
      • Recruiting
      • Henry Ford Health System
      • Contact: Marissa Gilbert, BSBME; Phone Number: 313-556-8422; Email: mgilber6@hfhs.org
      • Principal Investigator: Farzan Siddiqui, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoral Hypothermia Device; An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy.	Device: Intraoral Device; Device that circulates cooled water through the oral cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dysgeusia	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.	6 months after RT completion

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neoplasms by Site; Neoplasms; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Head and Neck Neoplasms; Taste Disorders
• Other Study ID Numbers: 15529-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No