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This study has been withdrawn prior to enrollment.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:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01767961
First received: January 11, 2013
Last updated: January 28, 2014
Last verified: January 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The total MDADI score will be analyzed using paired t-tests.

  • Perceived subjective swallowing function, assessed using the EAT-10 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The total EAT-10 score will be analyzed using paired t-tests.

  • Cervical esophageal stricture measurements [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A paired t-test will be used to assess the difference in cervical esophageal stricture diameters between the two treatment groups.


Enrollment: 0
Study Start Date: September 2013
Estimated 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

Ages Eligible for Study:   40 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767961

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Joshua Waltonen Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01767961     History of Changes
Other Study ID Numbers: CCCWFU 97312, NCI-2012-02165, P30CA012197
Study First Received: January 11, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014