Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
Henry Ford Health System
RECRUITING
Detroit
Contact Information
Primary
Marissa Gilbert, BSBME
mgilber6@hfhs.org
313-556-8422
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 15
Treatments
Experimental: Intraoral Hypothermia Device
An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy.
Sponsors
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov