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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01767961

Enrollment

Registered

2013-01-15

Start date

2013-09-30

Completion date

2015-01-31

Last updated

2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Cancer

Brief summary

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

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.

Interventions

PROCEDUREdiagnostic imaging

Undergo MBS

OTHERquestionnaire administration

Correlative studies

PROCEDUREquality-of-life assessment

Correlative studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026