Recruiting
Early Phase 1

Intraoral Hypothermia

Sponsor:

Henry Ford Health System

Code:

NCT06579248

Conditions

Head and Neck Cancer

Taste Dysfunction

Radiation Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoral Device

Study Details

Brief 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.

Conditions

Head and Neck Cancer

Taste Dysfunction

Radiation Therapy

Study ID

NCT06579248

Start date

Nov 12, 2024

Status verified date

Jan, 2026

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intraoral Hypothermia Device

An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy.

Interventions

Intraoral Device

Device that circulates cooled water through the oral cavity.

Primary outcome measure

  • Change in Dysgeusia [ Time Frame: 6 months after RT completion ]

Central Contacts and Locations

Central contacts

Marissa Gilbert, BSBME

313-556-8422mgilber6@hfhs.org

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202-2689

Contacts

Marissa Gilbert, BSBME

313-556-8422mgilber6@hfhs.org

Principal Investigator:

Farzan Siddiqui, MD PhD

More Information

Sponsor

Henry Ford Health System

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-01-14.