A Pilot Study Assessing Swallowing Function After Transoral Robotic Surgery (TORS) for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Dichotomized aspiration, measured via the maximum Penetration-Aspiration Scale (PAS) delineated from the MBS
时间窗: Baseline
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.
次要结局
- Cervical esophageal stricture measurements(Baseline)
- Swallowing function, assessed by the MDADI score(Baseline)
- Perceived subjective swallowing function, assessed using the EAT-10(Baseline)