Clinical study on the effect of Wenyang Lishui Prescription on drainage volume and upper limb function of breast cancer patients after operatio

Phase 1

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: ITMCTR2000004023
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified