Intraoral Hypothermia Device for Preserving Taste During Radiation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intraoral Device
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov