Clinical trial · Observational
Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing
NCT04658342CI-TRIAL-00083859terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): per Slow Accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oral Cancer Patients
- interventionNames
- Diagnostic Test: Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)
Primary outcomes (3)
- 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)
- description
- 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.
- 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)
- description
- This measure indicates how well the muscles of the upper esophageal sphincter relax to allow liquid and food to pass through.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.