ITMCTR2000004023尚未招募1 期
Clinical study on the effect of Wenyang Lishui Prescription on drainage volume and upper limb function of breast cancer patients after operation
Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- Male
入选标准
- •1) Female, >= 18 years old, <= 70 years old;
- •2) It was confirmed as primary infiltrating breast adenocarcinoma according to clinical physical examination, breast color ultrasound, mammography and hole-core needle puncture pathological examination;Immunohistochemical method (IHC) for breast cancer;All patients had measurable tumor lesions (at least one measurable lesion) before treatment, and the clinical stage was T1-4N0-3M0 (AJCC 8th edition staging criteria).
- •3) no prior treatment for breast cancer;
- •4) ECOG physical condition score of the subject is from 0 to 2;
- •5) Hematological and biochemical tests before treatment should meet the following requirements: white blood cell count (WBC)>= 4.0 x 10^9/L, neutrophilic granulocyte count (ANC) >= 1.5 x 10^9/L, and platelet count (PLT) >= 100 x 10^9/L; Hemoglobin (Hb) >= 90g/L;AST(sGOT) and ALT(sGPT) <= 1.5 times the upper limit of normal value, creatinine <= 1.5 times the upper limit of normal value, and total bilirubin <= 1.5 times the upper limit of normal value.
- •6) No serious damage to heart, liver or kidney function;
- •7) Agree to participate in clinical trial observation and cooperate with regular visitors;
- •8) Sign and date the written informed consent.
排除标准
- •1) Women breast-feeding during pregnancy and after pregnancy (blood -HCG excluded);
- •2) Confirmed women with distant metastasis of breast cancer;
- •3) Patients with evidence of sensory or motor neurological diseases;
- •4) Having a clear cardiovascular disease, severe coexisting disease or active infection, including known HIV infection;
- •5) Have other tumor history;
- •6) A history of immune diseases;
- •7) Unable to cooperate with the research for any reason, such as the following: language understanding, unable to go to the research center;
- •8) Other conditions or diseases that, in the opinion of the investigator, may bring obvious risks to the patient or confuse the results of the study and should be excluded.
研究者
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