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



Status:Not yet recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 89
Updated:3/1/2014
Start Date:September 2013

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

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

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.

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
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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mi
from
Winston-Salem, NC
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