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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (modified barium swallow)
Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.
|
Undergo MBS
Correlative studies
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
Time Frame: Baseline
|
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
Time Frame: Baseline
|
The total MDADI score will be analyzed using paired t-tests.
|
Baseline
|
|
Perceived subjective swallowing function, assessed using the EAT-10
Time Frame: Baseline
|
The total EAT-10 score will be analyzed using paired t-tests.
|
Baseline
|
|
Cervical esophageal stricture measurements
Time Frame: Baseline
|
A paired t-test will be used to assess the difference in cervical esophageal stricture diameters between the two treatment groups.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joshua Waltonen, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCWFU 97312
- P30CA012197 (U.S. NIH Grant/Contract)
- NCI-2012-02165 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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