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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoral Hypothermia Device | Experimental | An intraoral hypothermia device will be used to cool the oral cavity while subject's receive radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoral Device | Device | Device that circulates cooled water through the oral cavity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after RT completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marissa Gilbert, BSBME | Contact | 313-556-8422 | mgilber6@hfhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202-2689 | United States |
No individual participant data will be shared with other researchers.
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013651 | Taste Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |