Oropharyngeal Cancer Clinical Trial
Official title:
A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
Verified date | August 2017 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 89 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Swallowing function, assessed by the MDADI score | The total MDADI score will be analyzed using paired t-tests. | Baseline | |
Secondary | Perceived subjective swallowing function, assessed using the EAT-10 | The total EAT-10 score will be analyzed using paired t-tests. | Baseline | |
Secondary | Cervical esophageal stricture measurements | A paired t-test will be used to assess the difference in cervical esophageal stricture diameters between the two treatment groups. | Baseline |
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