Anthracycline cardiotoxicity during cancer treatment
Conditions
Interventions
Xinxuekang Group:Di'ao Xinxuekang Capsules, 2 capsules each time, 3 times a day, orally, for maintenance treatment until the end of follow-up
Placebo Group:Placebo Capsules, 2 capsules each time, 3 times a day, orally, for maintenance treatment until the end of follow-up
Sponsors
Jiangsu Province Hospital (The Affliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All candidate subjects must meet all the following conditions: 1) Those who meet the diagnostic criteria of stage I~III breast cancer and plan to receive chemotherapy (such as: those who have a high-risk recurrence tendency after stage I and consider chemotherapy; stage II/III preoperative neoadjuvant chemotherapy and/or postoperative adjuvant chemotherapy); 2) plan to use AC-based chemotherapy (intravenous injection of doxorubicin 60mg/m2 or epirubicin 90mg/m2 on the first day, first day Daily intravenous injection of cyclophosphamide 600mg/m2), for more than 4 consecutive cycles, the cumulative dose of doxorubicin reaches 240mg/m2 or more or the cumulative dose of epirubicin reaches 360mg/m2 or more; 3) Female, 18 years old = age =70 years of age; 4) The subject or the legal representative of the subject is informed of the nature of the study and agrees to participate in all the terms of the study, and signs an informed consent form approved by the ethics committee of the clinical center; 5) The subject agrees Accept all follow-up visits during the trial.
Exclusion criteria
Exclusion criteria: Candidate subjects will be excluded from this study if they meet any of the following conditions: 1) Participants in other clinical trials at the same time; 2) Patients with stage IV breast cancer; 3) Echocardiogram LVEF100 IU/L and/or aspartate aminotransferase>100 IU/L and/or serum creatinine>150 mmol /L); 6) unable or unwilling to stop using liver-protecting drugs due to various reasons; 7) having undergone radiotherapy or chemotherapy; 8) having used Di’ao Xinxuekang in the past or known to be allergic to Di’ao Xinxuekang; 9) suffering from mental illness; 10 ) Pregnant women, breastfeeding or preparing to conceive; 11) Other health problems that the researchers consider unsuitable for participating in this study; 12) Patients who are unwilling to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with myocardial marker high-sensitivity troponin T level increased by 2 times compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other myocardial markers;Electrocardiogram;Left ventricular ejection fraction;Safety indicators; | — |
Countries
China
Contacts
Public ContactWei Sun
Jiangsu Province Hospital (The Affliated Hospital with Nanjing Medical University)
Outcome results
None listed