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Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04658342
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Susan Thibeault, PhD
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cancer of Head and Neck
Arms & Interventions

Arms

: Oral Cancer Patients

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Wisconsin, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin

Madison, Wisconsin, 53792

Site Contact

Molly Knigge, MS, CCC-SLP

[email protected]

608-263-2861

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