Clinical trial · Interventional
Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer
A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to secure funding.
Summary
Brief summary (as posted)
This pilot clinical trial studies the modified barium swallow in measuring swallowing function after surgery in patients with oropharyngeal cancer who have undergone surgery. New diagnostic procedures, such as the modified barium swallow, may be effective in studying the side effects of cancer therapy in patients who received treatment for oropharyngeal cancer
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 |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic imaging | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (modified barium swallow)
- description
- Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.
- interventionNames
- Procedure: diagnostic imaging
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
- timeFrame
- Baseline
- description
- The maximum PAS score will be dichotomized into aspiration vs no aspiration. The highest (closest to 8 on the PAS scale) PAS score of the 10 swallows will be used for dichotomization. A PAS score of 6 or greater indicates aspiration, while a PAS score of 5 or less is indicative of no aspiration. McNemar's test for correlated proportions will be used to assess the difference between the two treatment groups.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have undergone TORS or CRT for oropharyngeal carcinoma 6-24 months prior at Wake Forest University Baptist Hospital (WFUBH) * In CRT treated participants, CRT had to be delivered as a primary modality with curative intent * In TORS treated participants, TORS had to be done as a primary modality with curative intent * Written informed consent * No evidence of recurrent disease or second primary tumors on physical examination Exclusion Criteria: * Previous head and neck surgery, radiation, or chemotherapy preceding TORS * Previous head and neck surgery preceding CRT * If CRT patient, candidacy for TORS is not met * Known neurologic dysfunction affecting swallowing * Evidence of recurrent or second primary cancers on examination * Patient pregnancy (due to radiation exposure risk to unborn fetus) * Inability to grant informed consent
References
Publications (0)
Data not yet available