NCT01767961

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oropharyngeal Cancer

Interventions

Type	Name	Description
PROCEDURE	diagnostic imaging	Undergo MBS
OTHER	questionnaire administration	Correlative studies
PROCEDURE	quality-of-life assessment	Correlative studies

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-01-15
• Last updated: 2017-08-10