NCT04196075已完成3 期
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Symptomatic relief and quality of life after AP
研究概览
简要总结
This is a prospective cohort study on the effect of Andrographis Paniculata (AP) on palliative management of patients with advanced or metastatic esophageal cancer. A total of 30 patients with locally advanced or metastatic squamous esophageal cancer will be recruited for the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Aged over 18
- •Locally advanced esophageal cancer with invasion or adherent to surrounding organs including trachea, recurrent laryngeal nerves and descending aorta;
- •Presence of distant metastasis;
- •Extensive lymph node metastasis to beyond surgical therapy
排除标准
- •Patients who cannot receive palliative stenting for dysphagia or under other conventional treatment including chemotherapy or chemoradiotherapy
- •Patients who are not willing to receive Chinese herbal medicines
- •Patients who do not consent for the study
研究组 & 干预措施
Andrographis Paniculata treatment
Experimental
Single lot of Andrographis paniculata (AP) concentrated granules (Andrographis Herba) will be manufactured by Nong's Company Limited under GMP standard
干预措施: Andrographis Paniculata (Drug)
结局指标
主要结局
Symptomatic relief and quality of life after AP
时间窗: 4 months
Symptomatic relief of Dysphagia and quality of life after treatment Dysphagia measured by Dysphagia score Quality of Life measured by EORTC-QLQ-C30
次要结局
- Survival(up to 36 months)
- Adverse events(up to 36 months)
- Difficulty to swallow(4 months)
- AP side effects(4 months)
研究者
Philip Wai Yan CHIU
Professor
Chinese University of Hong Kong
研究点 (1)
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