Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02165 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Unable to secure funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic imaging | Procedure | Undergo MBS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing function, assessed by the MDADI score | The total MDADI score will be analyzed using paired t-tests. | Baseline |
| Perceived subjective swallowing function, assessed using the EAT-10 | The total EAT-10 score will be analyzed using paired t-tests. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joshua Waltonen | Wake Forest University Health Sciences | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| questionnaire administration |
| Other |
Correlative studies |
|
| quality-of-life assessment | Procedure | Correlative studies |
|
|
| Baseline |
| 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 |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |