Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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PRIMARY OBJECTIVES: I. To compare aspiration in oropharyngeal carcinoma patients that underwent transoral robotic surgery (TORS) vs. chemoradiotherapy (CRT) via an objective instrument, the modified barium swallow (MBS). SECONDARY OBJECTIVES: I. To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a subjective instrument, the M.D. Anderson Dysphagia Inventory (MDADI) using the total MDADI score. II. To compare patient-perceived swallowing function of oropharyngeal carcinoma patients that underwent TORS vs. CRT via a second subjective instrument, the Eating Assessment Tool (EAT-10) using the total EAT-10 score. III. To estimate the correlation between the maximum Penetration Aspiration Scale (PAS) score and MDADI total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality. IV. To estimate the correlation between the maximum PAS score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality. V. To estimate the correlation between MDADI total score and EAT-10 total score in TORS or CRT oropharyngeal carcinoma patients regardless of treatment modality. VI. To estimate cervical esophageal stricture diameters after TORS vs. CRT via an objective instrument, the MBS. OUTLINE: Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.

Official Title
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A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer

Conditions
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Oropharyngeal Cancer

Intervention / Treatment
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* Procedure: diagnostic imaging
* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (modified barium swallow)<br>Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging. | Procedure: diagnostic imaging<br>* Undergo MBS<br>Other: questionnaire administration<br>* Correlative studies<br>Procedure: quality-of-life assessment<br>* Correlative studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing function, assessed by the MDADI score | The total MDADI score will be analyzed using paired t-tests. | Baseline | 
| Perceived subjective swallowing function, assessed using the EAT-10 | The total EAT-10 score will be analyzed using paired t-tests. | Baseline | 
| Cervical esophageal stricture measurements | A paired t-test will be used to assess the difference in cervical esophageal stricture diameters between the two treatment groups. | Baseline |