Pilot Study to Evaluate the Prevention and Safety of Doxorubicin-induced Cardiomyopathy Using Ext… (NCT05584163) | Clinical Trial Compass
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Pilot Study to Evaluate the Prevention and Safety of Doxorubicin-induced Cardiomyopathy Using Extracorporeal Shock Waves
South Korea72 participantsStarted 2020-10-01
Plain-language summary
Until now, patients receiving doxorubicin chemotherapy should use only the cumulative dose related to known cardiotoxicity, or if cardiotoxicity occurs below the known cumulative dose, use of doxorubicin as chemotherapy should be stopped. In this study, in patients with normal heart function receiving doxorubicin chemotherapy, extracorporeal shock wave therapy was performed 3 times a week during chemotherapy, and 1 cycle of extracorporeal shock wave therapy was performed (every 6 weeks) every 2 cycles of chemotherapy. Echocardiography should be performed at baseline and every 4 cycles of chemotherapy, and follow-up 3 months after chemotherapy is completed to compare the incidence of cardiomyopathy caused by chemotherapy between the two groups.
Who can participate
Age range19 Years
SexFEMALE
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Inclusion criteria
✓. Breast cancer patients receiving doxorubicin chemotherapy (for patients with operable breast cancer who receive doxorubicin with neoadjuvant or adjuvant chemotherapy)
✓. Patients who are expected to receive at least 3 cycles of doxorubicin chemotherapy after registration and who can receive at least 2 extracorporeal shock wave therapy
✓. Those with a left ventricular ejection fraction of 50% or more at screening
Exclusion criteria
✕. Subjects under the age of 19
✕. Those who have implanted an intracardiac device (implantable defibrillator, pacemaker)