Clinical trial NCT01767961: Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer
Official title: A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Oropharyngeal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
timeFrame: Baseline
Secondary outcomes:
measure: Swallowing function, assessed by the MDADI score
timeFrame: Baseline
measure: Perceived subjective swallowing function, assessed using the EAT-10
timeFrame: Baseline
measure: Cervical esophageal stricture measurements
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joshua Waltonen
role: PRINCIPAL_INVESTIGATOR
References: