Intraoral Hypothermia Device for Preserving Taste During Radiation

Exclusion Criteria11

• 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.