Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- incidence of grade 3-4 diarrhea
研究概览
简要总结
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.
详细描述
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Meet the following two conditions:
- •Planned administration of pyrotinib ≥ 21 days;
- •Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib;
- •Age ≥ 18 years old;
- •ECOG PS 0-2；
- •Life expectancy ≥ 6 months;
- •Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up
排除标准
- •Those who may be allergic to pyrotinib or excipients;
- •It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc;
- •Patients with biliary obstruction;
- •Participate in other diarrhea related clinical trials;
- •Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptives during the whole test period;
- •according to the researchers' judgment, there are serious diseases that endanger the safety of patients, or affect the patients to complete the study (including, but not limited to, severe hypertension and severe diabetes, which can not be controlled by drugs).
- •Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.
研究组 & 干预措施
Treatment arm
干预措施: Traditional Chinese Medicine (Drug)
结局指标
主要结局
incidence of grade 3-4 diarrhea
时间窗: From the beginning of taking traditional Chinese medicine to the 21st day
The number of stools per day increased by ≥ 7 compared with baseline; Incontinence, indication of hospitalization; Compared with baseline, the yield of stoma increased significantly; Daily activities are limited.Life threatening diarrhea
次要结局
未报告次要终点