Effects of Oral Cancer Treatments on Upper Esophageal Opening During Swallowing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Upper Esophageal Maximum Admittance as measured by HRM among time points of oral cancer treatment.
研究概览
简要总结
The purpose of this study is to investigate post-operative and post-radiation upper esophageal sphincter opening measures in oral cancer patients, compare measures to age- and gender-matched healthy adults, and determine relationships with patient swallowing outcomes and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral cancer that includes tongue or floor of mouth clinical stage T1 or higher
- •May have disease that extends to base of tongue or other site as long as floor of mouth or tongue are involved
- •Adults at least 18 years of age
排除标准
- •Oral cancer of the lip, cheek, palate or other site not impacting tongue or floor of mouth musculature
- •History of floor of mouth, tongue base, pharyngeal or laryngeal surgical resection
- •History of radiation treatment to the head and neck
- •History of dysphagia prior to onset of oral cancer symptoms
- •Allergy to lidocaine, barium, adhesive tape or apple flavoring
- •Woman of childbearing years who are pregnant
结局指标
主要结局
Change in Upper Esophageal Maximum Admittance as measured by HRM among time points of oral cancer treatment.
时间窗: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
This measure provides understanding of how well throat muscles pull the upper esophagus open to allow flow of liquid or food from the throat to the esophagus.
Change in Upper Esophageal Integrated Relaxation Pressure (IRP) as measured by HRM
时间窗: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
This measure indicates how well the muscles of the upper esophageal sphincter relax to allow liquid and food to pass through.
Change in Hypopharyngeal Pressure at Nadir Impedence (PNI) as measured by HRM
时间窗: Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation)
This measure indicates how well the upper esophagus stretches open to accept the liquid or food.
次要结局
- Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Grading Scale Score(Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation))
- Change in the MD Anderson Dysphagia Inventory (MDADI) Scores among time points of oral cancer treatment(Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation))
- Statistical Correlation between MDADI and Maximum Admittance(Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation))
- Statistical Correlation between DIGEST and Maximun Admittance(Approximately 4 weeks (post-surgery), and up to 6 months (3 months post-radiation))