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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Henry Ford Health System
  Detroit, Michigan, United States Recruiting

Study contacts

• Study coordinator: Marissa Gilbert, BSBME
• Email: mgilber6@hfhs.org
• Phone: 313-556-8422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.