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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/SURGERY/OTOLARYNGOLOGY | Other Identifier | UW Madison | |
| A539770 | Other Identifier | UW Madison | |
| Protocol Version 4/26/2022 | Other Identifier | UW Madison | |
| UW20051 | Other Identifier | UWCCC |
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per Slow Accrual
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The purpose of this study is to investigate post-operative and post-radiation upper esophageal sphincter opening measures in oral cancer patients, compare measures to age- and gender-matched healthy adults, and determine relationships with patient swallowing outcomes and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Cancer Patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM) | Diagnostic Test | The Videofluoroscopic Imaging (VFSS) is done by inserting a small catheter into the nose and down the throat. The catheter is approximately .4 millimeters in diameter. A trained speech-language pathologist will insert the catheter after applying numbing medicine, or topical anesthetic, inside the nose. The high-resolution manometry (HRM) is a swallowing pressure test done at the same time as the VFSS. The HRM will measure how strong the throat muscle squeeze the liquids and foods that a person swallows. The VFSS and HRM will occur about one month after surgery and three months after the completion of the radiation treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Esophageal Maximum Admittance as measured by HRM among time points of oral cancer treatment. | This measure provides understanding of how well throat muscles pull the upper esophagus open to allow flow of liquid or food from the throat to the esophagus. | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |
| Change in Upper Esophageal Integrated Relaxation Pressure (IRP) as measured by HRM | This measure indicates how well the muscles of the upper esophageal sphincter relax to allow liquid and food to pass through. | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |
| Change in Hypopharyngeal Pressure at Nadir Impedence (PNI) as measured by HRM | This measure indicates how well the upper esophagus stretches open to accept the liquid or food. | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the MD Anderson Dysphagia Inventory (MDADI) Scores among time points of oral cancer treatment | Measurement of swallowing-related quality of life. This patient-rated tool has a maximum score of 100 points total across 20 questions, where the highest score indicates better overall swallow-related quality of life. | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population are patients with a diagnosis of oral and neck cancer that are selected at the primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Susan Thibeault, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grading Scale Score | Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade of 0 to 4, where lower grade reflects better swallow function | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |
| Statistical Correlation between MDADI and Maximum Admittance | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |
| Statistical Correlation between DIGEST and Maximun Admittance | Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) |