Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer
NCT ID: NCT01767961
Last Updated: 2017-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-09-30
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
diagnostic imaging
Undergo MBS
questionnaire administration
Correlative studies
quality-of-life assessment
Correlative studies
Interventions
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diagnostic imaging
Undergo MBS
questionnaire administration
Correlative studies
quality-of-life assessment
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
89 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Joshua Waltonen
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Other Identifiers
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NCI-2012-02165
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 97312
Identifier Type: -
Identifier Source: org_study_id
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