A prospective randomized controlled study for the protective effect of Honghuang Decoction on cardiotoxicity of anthracyclines based on regulating oxidative stres

Jiangsu Provincial Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

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•1.Pathologically confirmed breast cancer is treated with anthracycline-containing chemotherapy regimens, including (adriamycin A or epirubicin E combined with cyclophosphamide C*4): doxorubicin 60 mg/m2 (or epirubicin 90 mg/m2) cyclophosphamide 600 mg/m2.
•2.Basic cardiac function was good before chemotherapy: NYHA cardiac function grade I; LVEF > 55%; GLS > 18; ECG was normal; cardiac troponin was in normal range.
•3.Perfect the relevant examinations before chemotherapy and eliminate the contraindications of chemotherapy.
•4.The age of the patients ranged from 18 to 70 years.
•5.Informed consent, volunteer subjects. The process of obtaining informed consent should comply with GCP.

•1.Persons with disabilities prescribed by law do have a history of alcohol and drug abuse.
•2.Chemotherapy contraindication for various diseases.
•3.Patients who are participating in clinical trials of other drugs.
•4.Pregnant and lactating women.
•5.Those who cannot give full informed consent due to intellectual or behavioral disorders.
•6.Suspected or true history of alcohol and drug abuse.
•7.According to the judgement of the researcher, other pathological changes, such as frequent changes in working environment, which can reduce the possibility of enrollment or complicate enrollment, are liable to lead to loss of interviews.

发起方

Jiangsu Provincial Hospital of Traditional Chinese Medicine