Intraoral Hypothermia Device for Preserving Taste During Radiation

Launched by HENRY FORD HEALTH SYSTEM · Aug 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special device that cools the mouth during radiation therapy for patients with head and neck cancer. The goal is to see if using this cooling device can help preserve the sense of taste, which often declines due to radiation treatment. Researchers believe that keeping the mouth cooler might protect it from damage caused by radiation, making the experience more comfortable for patients.

To participate in this study, you need to be at least 18 years old and undergoing radiation and chemotherapy for specific types of advanced throat cancer. You should also be in good enough health to complete some forms and questionnaires about your experience. If you join the study, you will use the cooling device during your radiation sessions. It’s important to know that certain patients, such as those with severe allergies to the device materials or who have already lost their sense of taste, will not be eligible. If you're interested and meet the criteria, this trial could be a way to help improve taste preservation during your treatment.

Gender

ALL

Eligibility criteria

• 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 cetuximab.
• 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 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.