Trastuzumab-induced cardiotoxicity
Conditions
Interventions
Test group:Chinese medicine
Control group:Placebo
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female 2. Age 30-75 years 3. Patients with breast cancer who are about to receive or are receiving trastuzumab or trastuzumab in combination with pertuzumab, as evaluated by the specialist 4. Expected survival time and treatment time are greater than 6 months 5. KPS score greater than or equal to 60 6. Patients whose TCM classification is compatible with TCM (diagnostic criteria refer to: "Technical Guidelines for Clinical Research on New Chinese Medicines for Chronic Heart Failure") 7. Accept random assignment 8. Voluntarily participate in the clinical trial and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women 2. Impaired liver and kidney function (ALT, AST, serum creatinine levels greater than 2 times the upper limit of normal and above) 3. Hypersensitivity to drugs designed for this test 4. Combination of organic heart disease, congenital heart disease, cardiomyopathy, myocardial injury, history of myocardial ischemia or severe cardiac insufficiency before the onset of breast cancer 5. Those who have demonstrated severe cardiotoxic events before treatment, such as cardiac function class IV, LVEF <50% and combined with symptoms related to heart failure. 6. Those who are taking anti-tumor herbal medicines that duplicate the components of the herbal medicines involved in this trial 7. Those who have participated in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| left ventricular ejection fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular end-diastolic volume;Cardiac Function Classification(NYHA);Myocardial enzyme profile;rain Natriuretic Peptide/BNP;NT-proBNP;Chinese Medicine Symptom Scale; | — |
Countries
Chian
Contacts
Public ContactChen Xinlin
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed