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NCT Number: NCT06579248

Intraoral Hypothermia Device for Preserving Taste During Radiation

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Radiation Therapy Sensation Disorders Signs and Symptoms Taste Disorders Taste Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Henry Ford Health System

Detroit, Michigan, 48202-2689, United States

Location status: Recruiting

Location contact

Farzan Siddiqui, MD PhD

PRINCIPAL_INVESTIGATOR

Marissa Gilbert, BSBME

CONTACT

[email protected]

313-556-8422

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoral Device

Device

Device that circulates cooled water through the oral cavity.

Primary outcomes

  1. Change in Dysgeusia

    Time frame: 6 months after RT completion

    Taste will be measured objectively using Burghart taste strips in five different concentrations of salty, sweet, sour, bitter, and umami. Taste will be assessed on a yes/no scale to reflect the ability to correctly identify taste category.

    Taste will be measured subjectively with a series of previously-validated, patient-reported taste-related questions. The questions comprise of a modified Chemotherapy-induced Taste Alteration Scale (CiTAS), one question from the Head and Neck Quality of Life questionnaire (HNQOL, question 2H) and one question from the University of Washington Head and Neck-specific Quality of Life questionnaire (UWQOL, question 9).

    The CiTAS uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste.

    The HNQOL uses a scale of 1-5, with 1 meaning taste is normal and 5 being unable to taste.

    The UWQOL uses a scale of 1-4, with 1 meaning taste is normal and 4 being unable to taste.

    Questionnaires are used together to quantify change in taste.

Study contacts

Contact information is provided by the study sponsor or research team.

Marissa Gilbert, BSBME

CONTACT

[email protected]

313-556-8422

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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