Intraoral Hypothermia Device for Preserving Taste During Radiation

Phase

Condition

Human Papilloma Virus (Hpv)

Nasopharyngeal Cancer

Cancer Treatment

Treatment

Intraoral Device

Clinical Study ID

NCT06579248

15529-01

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Patients being treated with combination radiation therapy and chemotherapy (definitive) for locally advanced (AJCC 8th cT3-4 or cN+) squamous cell carcinoma ofthe larynx.
Age ≥ 18.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Patients will engage in the informed consent process and provide study-specificinformed consent prior to study entry and must be able to fill out toxicity andquality of life related questionnaires.
Patients should be concurrently treated with any of the following chemotherapydrugs: cisplatin, carboplatin, and cetuximab.

Exclusion

Exclusion Criteria:

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 neckcancer.
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 completionis adequate if recorded on the form daily.
Patients with uncontrolled serious illness including, but not limited to, ongoing orserious active infection requiring IV antibiotics for over 30 days, symptomaticcongestive heart failure, unstable angina pectoris, cardiac arrhythmia other thanchronic, stable atrial fibrillation, immunocompromised state, significant hepaticinsufficiency, significant hematological disease, and any serious or unstablepsychological condition.
Patients who are on any of the following medication that cannot find a suitablesubstitute during the study period: acetazolamide, maribavir (TAK-620, Phase 3 trialdrug), eszopiclone, topiramate, captopril, lithium, procainamide, terbinafine, andamiodarone.
Patients who have taste loss at baseline, assessed subjectively and objectively atthe first encounter, will be excluded from the study and all analysis. They will bereplaced with a new patient.
Patients who have tested positive for COVID-19 during the study period.

Study Design