A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
40 Years
89 Years
Both
Oropharyngeal Cancer
Trial Information
A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
Outcome Description:
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.
Outcome Time Frame:
Baseline
Safety Issue:
No
Principal Investigator
Joshua Waltonen
Investigator Role:
Principal Investigator
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 97312
NCT ID:
NCT01767961
Start Date:
September 2013
Completion Date:
Related Keywords:
- Oropharyngeal Cancer
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
Name | Location |
|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
