Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

Cancer of Head and Neck Clinical Trial

Official title:

Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658342
• Other study ID #: 2020-0495
• Secondary ID: SMPH/SURGERY/OTO
• Status: Recruiting
• Start date: April 16, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Wisconsin, Madison
• Contact: Molly Knigge, MS, CCC-SLP
• Phone: 608-263-2681
• Email: knigge[@]surgery.wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms
• Mouth Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Statistical Correlation between MDADI and Maximum Admittance		Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
Secondary	Statistical Correlation between DIGEST and Maximun Admittance		Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)