Actively Recruiting
Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx
Led by Henry Ford Health System · Updated on 2026-01-14
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Radiation therapy for head and neck cancer, especially squamous cell carcinoma of the larynx, can cause problems with taste. Researchers are studying if using a cooling device inside the mouth during radiation can help protect or reduce the loss of taste. This early phase 1 study explores the feasibility of this approach and aims to understand if cooling can lower damage to taste function caused by radiation. Participants will use an intraoral hypothermia device that circulates cooled water through the mouth while receiving combination radiation therapy and chemotherapy. The device is applied during the radiation treatments to cool the oral cavity and potentially preserve taste function. This study focuses on patients undergoing definitive treatment with chemotherapy drugs like cisplatin, carboplatin, or cetuximab, alongside radiation. During the study, participants will complete questionnaires related to taste changes, toxicity, and quality of life. Researchers will measure taste dysfunction six months after radiation therapy ends to evaluate changes. Patients will be monitored for tolerance of the device and any side effects. The total study participation includes the treatment period and follow-up assessments to assess the device's impact on preserving taste.
CONDITIONS
Brief Title
Intraoral Hypothermia Device for Preserving Taste During Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with combination radiation therapy and chemotherapy for locally advanced squamous cell carcinoma of the larynx
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Able to provide informed consent and complete toxicity and quality of life questionnaires
- Receiving chemotherapy drugs such as cisplatin, carboplatin, or cetuximab concurrently with radiation
You will not qualify if you...
- Receiving other therapies intended to reduce taste dysfunction
- Having metastatic disease
- Allergies or sensitivities to materials in the intraoral device
- Prior chemotherapy or radiation therapy for head and neck cancer
- Unable or unwilling to use or tolerate the intraoral device
- Current or recent cigarette smokers within 3 months before treatment
- Unable to complete required study forms (verbal completion allowed if recorded)
- Having uncontrolled serious illnesses such as active infections needing IV antibiotics over 30 days, symptomatic heart failure, unstable angina, certain heart arrhythmias, immunocompromised state, severe liver or blood diseases, or serious psychological conditions
- Taking medications like acetazolamide, maribavir, eszopiclone, topiramate, captopril, lithium, procainamide, terbinafine, or amiodarone without suitable substitutes during the study
- Having baseline taste loss
- Testing positive for COVID-19 during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiation therapy
Participants use an intraoral hypothermia device to cool the oral cavity during radiation therapy for squamous cell carcinoma of the larynx.
Visits aligned with radiation therapy schedule
Duration - 6 months after radiation therapy completion
Participants are monitored for changes in taste function up to 6 months after completion of radiation therapy.
Periodic follow-up visits up to 6 months
Trial Site Locations
Total: 1 location
1
Henry Ford Health System
Detroit, Michigan, United States, 48202-2689
Actively Recruiting
Research Team
M
Marissa Gilbert, BSBME
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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