Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Choking symptom objective response rate
研究概览
简要总结
The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •confirmed pathological esophageal squamous cell carcinoma
- •≥18 years old
- •the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- •no previous anti-tumor treatment
- •no esophageal bleeding or fistula
- •adequate hemocyte count, normal hepatic and renal functions
- •Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score
排除标准
- •lactating or pregnant women
- •known hypersensitivity or allergy to any kind green tea extract
- •placement of small intestinal feeding tube or endoscopic stent treatment
- •unable or refusing to take oral liquids
结局指标
主要结局
Choking symptom objective response rate
时间窗: baseline and up to 7 days post-treatment
Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)
Imaging objective response rate
时间窗: Change from Baseline esophageal stenosis size at 7 days
Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT
Pain symptom objective response rate
时间窗: baseline and up to 7 days post-treatment
Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable)
次要结局
- Albumin change(baseline and up to 7 days post-treatment)
- prealbumin change(baseline and up to 7 days post-treatment)
- Number of Participants with Adverse Events(baseline and up to 7 days post-treatment)
研究者
Han Xi Zhao
Deputy Chief Physician
Shandong Cancer Hospital and Institute