Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx
Henry Ford Health System
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cetuxim…
Interventions
- DeviceIntraoral Device
Device that circulates cooled water through the oral cavity.
Location
- Henry Ford Health SystemDetroit, Michigan