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

Oropharyngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01767961
• Other study ID #: CCCWFU 97312
• Secondary ID: NCI-2012-02165P3
• Status: Withdrawn
• Phase: N/A
• First received: January 11, 2013
• Last updated: August 8, 2017
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Procedure:
• diagnostic imaging
Undergo MBS

Other:
• questionnaire administration
Correlative studies

Procedure:
• quality-of-life assessment
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Swallowing function, assessed by the MDADI score	The total MDADI score will be analyzed using paired t-tests.	Baseline
Secondary	Perceived subjective swallowing function, assessed using the EAT-10	The total EAT-10 score will be analyzed using paired t-tests.	Baseline
Secondary	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