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

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Oropharyngeal Cancer

Treatments: Procedure: quality-of-life assessment; Other: questionnaire administration; Procedure: diagnostic imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01767961

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 97312

NCI-2012-02165 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 40 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic (modified barium swallow)

Experimental group

Description:

Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment

Procedure: diagnostic imaging