Cooling device to preserve taste during radiation for head and neck cancer

Study of a Novel Intraoral Hypothermia Device for Preserving Taste During Radiation Therapy for Squamous Cell Carcinoma of the Larynx

This study is testing a cooling device to see if it can help people with advanced throat cancer keep their sense of taste while they undergo radiation and chemotherapy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henry Ford Health System (Academic / other)
• Drugs / interventions: cetuximab, chemotherapy, radiation
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT06579248 on ClinicalTrials.gov

What this trial studies

This research investigates the use of an intraoral cooling device during radiation therapy for patients with locally advanced squamous cell carcinoma of the larynx. The aim is to determine if cooling normal tissues can mitigate the taste dysfunction commonly caused by radiation treatment. Patients will be treated with a combination of radiation and chemotherapy while using the device, and their taste function will be monitored throughout the process. The study focuses on the feasibility and effectiveness of this approach in preserving taste sensation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced squamous cell carcinoma of the larynx receiving definitive radiation and chemotherapy.

Not a fit: Patients with metastatic disease or those receiving other therapies aimed at reducing taste dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help maintain taste function in patients undergoing radiation therapy for head and neck cancer.

How similar studies have performed: Preliminary studies have shown promise in using cooling techniques to reduce radiation damage, suggesting potential success for this approach.

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.

Where this trial is running

Detroit, Michigan

• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Marissa Gilbert, BSBME

Conditions Head and Neck Cancer; Taste Dysfunction; Radiation Therapy