Clinical trial NCT04658342: Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing
Official title: Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer of Head and Neck
Keywords: quality of life
swallowing outcomes
oral cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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
* 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

Primary outcomes:
measure: Change in Upper Esophageal Maximum Admittance as measured by HRM among time points of oral cancer treatment.
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
measure: Change in Upper Esophageal Integrated Relaxation Pressure (IRP) as measured by HRM
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
measure: Change in Hypopharyngeal Pressure at Nadir Impedence (PNI) as measured by HRM
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
Secondary outcomes:
measure: Change in the MD Anderson Dysphagia Inventory (MDADI) Scores among time points of oral cancer treatment
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
measure: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grading Scale Score
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
measure: Statistical Correlation between MDADI and Maximum Admittance
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
measure: Statistical Correlation between DIGEST and Maximun Admittance
timeFrame: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Susan Thibeault, PhD
role: PRINCIPAL_INVESTIGATOR
References: