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

This study has been withdrawn prior to enrollment.
(Unable to secure funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767961
First Posted: January 15, 2013
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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

Condition Intervention
Oropharyngeal Cancer Procedure: diagnostic imaging Other: questionnaire administration Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures:
  • Swallowing function, assessed by the MDADI score [ Time Frame: Baseline ]
    The total MDADI score will be analyzed using paired t-tests.

  • Perceived subjective swallowing function, assessed using the EAT-10 [ Time Frame: Baseline ]
    The total EAT-10 score will be analyzed using paired t-tests.

  • Cervical esophageal stricture measurements [ Time Frame: Baseline ]
    A paired t-test will be used to assess the difference in cervical esophageal stricture diameters between the two treatment groups.


Enrollment: 0
Actual Study Start Date: September 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (modified barium swallow)
Patients undergo the modified barium swallow, comprising swallowing boluses of thin liquid barium, barium honey, barium pudding, and barium crackers while undergoing fluoroscopic imaging.
Procedure: diagnostic imaging
Undergo MBS
Other: questionnaire administration
Correlative studies
Procedure: quality-of-life assessment
Correlative studies
Other Name: quality of life assessment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767961


Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Joshua Waltonen Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01767961     History of Changes
Other Study ID Numbers: CCCWFU 97312
NCI-2012-02165 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
First Submitted: January 11, 2013
First Posted: January 15, 2013
Last Update Posted: August 10, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases