Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

NCT04658342 | Terminated DMC

• 5 other identifiers: 2020-0495SMPH/SURGERY/OTOLARYNGOLOGYA539770Protocol Version 4/26/2022UW20051
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of Head and Neck

Keywords

quality of life; swallowing outcomes; oral cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in the MD Anderson Dysphagia Inventory (MDADI) Scores among time points of oral cancer treatment

  Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)

• Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grading Scale Score

  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)

Study Arms (1)

Oral Cancer Patients

Diagnostic Test: Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)

Interventions

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.

Oral Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Susan Thibeault, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: April 16, 2021
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)