NCT01767961

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

January 11, 2013

Last Update Submit

August 8, 2017

Conditions

Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

  • Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS

    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.

    Baseline

Secondary Outcomes (3)

  • Swallowing function, assessed by the MDADI score

    Baseline

  • Perceived subjective swallowing function, assessed using the EAT-10

    Baseline

  • Cervical esophageal stricture measurements

    Baseline

Study Arms (1)

Diagnostic (modified barium swallow)

EXPERIMENTAL

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 imagingOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

diagnostic imagingPROCEDURE

Undergo MBS

Diagnostic (modified barium swallow)
questionnaire administrationOTHER

Correlative studies

Diagnostic (modified barium swallow)
quality-of-life assessmentPROCEDURE

Correlative studies

Also known as: quality of life assessment
Diagnostic (modified barium swallow)

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Joshua Waltonen

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 15, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 10, 2017

Record last verified: 2017-08