Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 83
- 主要终点
- Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
研究概览
简要总结
The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •pathologically documented LC
- •considered medically inoperable stage IIIA or stage IIIB or limited stage small cell lung cancer
- •age ≥18 years
- •Karnofsky ≥70
- •adequate hematologic, hepatic and renal function
- •FEV1 > 800 cc
- •mean esophagus dose >20 Gy
- •Exclusion criteria were as follows:
- •a known allergy or hypersensitivity to EGCG
- •pregnancy or lactation
- •prior radiation to the thorax
排除标准
- 未提供
研究组 & 干预措施
prophylactic EGCG group
干预措施: EGCG (Drug)
therapeutic EGCG group
干预措施: EGCG (Drug)
conventional therapy group
干预措施: mLDG (Drug)
结局指标
主要结局
Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
时间窗: Each patient will be enrolled for a 8-9 week trial
次要结局
- Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation(Each patient will be enrolled for a 8-9 week trial)
- Improved quality of life with usage of EGCG for treatment of radiation-esophagitis in patient with lung cancer.(Each patient will be enrolled for a 8-9 week trial)
研究者
Han Xi Zhao
Principal Investigator
Shandong Cancer Hospital and Institute