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Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

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ClinicalTrials.gov Identifier: NCT04658342
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this study is to investigate pre-operative, 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.

Condition or disease Intervention/treatment
Cancer of Head and Neck Diagnostic Test: Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Group/Cohort Intervention/treatment
Oral Cancer Patients Diagnostic Test: 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 before surgery, about one month after surgery and three months after the completion of the radiation treatment.





Primary Outcome Measures :
  1. Change in Upper Esophageal Maximum Admittance as measured by HRM among time points of oral cancer treatment. [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]
    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.

  2. Change in Upper Esophageal Integrated Relaxation Pressure (IRP) as measured by HRM [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]
    This measure indicates how well the muscles of the upper esophageal sphincter relax to allow liquid and food to pass through.

  3. Change in Hypopharyngeal Pressure at Nadir Impedence (PNI) as measured by HRM [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]
    This measure indicates how well the upper esophagus stretches open to accept the liquid or food.


Secondary Outcome Measures :
  1. Change in the MD Anderson Dysphagia Inventory (MDADI) Scores among time points of oral cancer treatment [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]
    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.

  2. Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grading Scale Score [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]
    Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade of 0 to 4, where lower grade reflects better swallow function

  3. Statistical Correlation between MDADI and Maximum Admittance [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]
  4. Statistical Correlation between DIGEST and Maximun Admittance [ Time Frame: Baseline (pre-surgery), approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population are patients with a diagnosis of oral and neck cancer that are selected at the primary care clinic.
Criteria

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
  • Nodal disease OR perineural invasion OR lymphovascular invasion
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658342


Contacts
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Contact: Molly Knigge, MS, CCC-SLP 608-263-2681 knigge@surgery.wisc.edu
Contact: Mary Lynch 608-263-4864 lynchm@surgery.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Molly Knigge, MS, CCC-SLP    608-263-2861    mknigge@uwhealth.org   
Contact: Mary Lynch, BA    608-263-4864    lynchm@surgery.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Susan Thibeault, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04658342    
Other Study ID Numbers: 2020-0495
SMPH/SURGERY/OTOLARYNGOLOGY ( Other Identifier: UW Madison )
A539770 ( Other Identifier: UW Madison )
Protocol Version 6/8/2020 ( Other Identifier: UW Madison )
UW20051 ( Other Identifier: UWCCC )
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
quality of life
swallowing outcomes
oral cancer
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases