Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer of Head and Neck
• Intervention / Treatment: Diagnostic test: Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Molly Knigge, MS, CCC-SLP; Phone Number: 608-263-2681; Email: knigge@surgery.wisc.edu
• Study Contact Backup: Name: Mary Lynch; Phone Number: 608-263-4864; Email: lynchm@surgery.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin
      • Contact: Molly Knigge, MS, CCC-SLP; Phone Number: 608-263-2861; Email: mknigge@uwhealth.org
      • Contact: Mary Lynch, BA; Phone Number: 608-263-4864; Email: lynchm@surgery.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 about one month after surgery and three months after the completion of the radiation treatment.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Susan Thibeault, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; oral cancer; swallowing outcomes
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mouth Neoplasms
• Other Study ID Numbers: 2020-0495 (M D Anderson Cancer Center); A539770 (Other Identifier: UW, Madison); SMPH/SURGERY/OTOLARYNGOLOGY (Other Identifier: UW, Madison); UW20051 (Other Identifier: UWCCC); Protocol Version 4/26/2022 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No