Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Diagnostic Test: Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Oral cancer that includes tongue or floor of mouth clinical stage T1 or higher May have disease that extends to base of tongue or other site as long as floor of mouth or tongue are involved Adults at least 18 years of age Exclusion Criteria: Oral cancer of the lip, cheek, palate or other site not impacting tongue or floor of mouth musculature History of floor of mouth, tongue base, pharyngeal or laryngeal surgical resection History of radiation treatment to the head and neck History of dysphagia prior to onset of oral cancer symptoms Allergy to lidocaine, barium, adhesive tape or apple flavoring Woman of childbearing years who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Cancer Patients<br> | Diagnostic Test: Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, swallowing outcomes, oral cancer