Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing
NCT ID: NCT04658342
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
5 participants
OBSERVATIONAL
2021-04-16
2023-03-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Oral Cancer Patients
Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)
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.
Interventions
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Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Susan Thibeault, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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2020-0495
Identifier Type: -
Identifier Source: org_study_id
SMPH/SURGERY/OTOLARYNGOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
A539770
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 4/26/2022
Identifier Type: OTHER
Identifier Source: secondary_id
UW20051
Identifier Type: OTHER
Identifier Source: secondary_id