RECRUITING

Intraoral Hypothermia Device for Preserving Taste During Radiation

Conditions

Head and Neck Cancer Taste Dysfunction Radiation Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-12

Study Completion:2025-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06579248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Marissa Gilbert, BSBME

CONTACT

313-556-8422

mgilber6@hfhs.org

Study Locations (Sites)

Henry Ford Health System

Detroit, Michigan, 48202-2689

United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12

Study Completion Date2025-08-30

Study Record Updates

Study Start Date2024-11-12

Study Completion Date2025-08-30

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Cancer
Taste Dysfunction
Radiation Therapy