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Recruiting NCT06579248

Intraoral Hypothermia Device for Preserving Taste During Radiation

Early Phase I Interventional Head and Neck Cancer Taste Dysfunction Radiation Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoral Device.
Who it may be relevant to
Registry conditions: Head and Neck Cancer, Taste Dysfunction, Radiation Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Intraoral Device
    Device that circulates cooled water through the oral cavity.

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Henry Ford Health System — Detroit

Identifiers

NCT: NCT06579248 · 15529-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗