Intraoral Hypothermia Device for Preserving Taste During Radiation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Intraoral Device
DeviceDevice that circulates cooled water through the oral cavity.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Intraoral Hypothermia DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Dysgeusia
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.
Time frame
6 months after RT completionSponsors and contacts
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Source ClinicalTrials.gov