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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.
Extracorporeal shock wave therapy cycle
It was assumed that the incidence of cardiomyopathy in patients receiving extracorporeal shock wave therapy was low. Cardiomyopathy is defined as â‘ a decrease in the absolute value of left ventricular ejection fraction by 10% or more or â‘¡ a decrease in the absolute value of LV global longitudinal strain (GLS) by 8% or more. In this study, cardiomyopathy caused by the definition of LV global longitudinal strain (GLS) was set as the primary efficacy evaluation.
Therefore, when the target number of subjects is set according to the definition that the LV global longitudinal strain (GLS) set as the primary efficacy evaluation variable is reduced to less than 17.5%, the absolute LVGLS value is the dependent variable, the significance level is 0.05, and the power is based on 85%. Therefore, when the ratio between groups is 1:1, the mean of the treated group is expected to be 19.6%, the mean of the untreated group is expected to be 18.0%, and when the standard deviations are applied as 2.4% and 2.4%, respectively, when using the G*Power 3.1 program, 33 people are required for each calculated group. Considering the dropout rate of 10%, 36 people each, a total of 72 subjects, is calculated as the required number of subjects.
Observational items/clinical examination items and observational examination method Basic information: Acquired at the time of clinical research registration
Left ventricular ejection fraction (LVEF), Left ventricular end-diastolic dimension (LVEDD), Left ventricular end-systolic dimension (LVESD), Inter-ventricular septal diastolic phase (IVSd), Posterior wall thickness (PWd), Mitral inflow pattern, Mitral valve tissue doppler, Rightly ventricular systolic pressure (RVSP), Left ventricular (LV) global longitudinal strain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Group not using drugs used for the prevention of cardiomyopathy caused by doxorubicin, including extracorporeal shock wave | |
| ESWT treatment group | Experimental | Group receiving extracorporeal shock wave therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock waves | Device | 3 times of extracorporeal shock wave therapy is performed, and 1 cycle of extracorporeal shock wave therapy is performed (every 6 weeks) every 2 cycles of chemotherapy. Echocardiography is performed at baseline and every 4 cycles of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy induced cardiomyopathy | Primary efficacy endpoint: Cardiomyopathy is defined as the LV longitudinal strain value, an echocardiographic index, and the incidence rate of cardiomyopathy between the experimental group and the control group is compared. The definition of cardiomyopathy in LV longitudinal strain is as follows - When the strain value of the longitudinal axis of the left ventricle (LV global longitudinal strain) decreases to less than -17.5% or reduction of >15% compared to the baseline value. | 3months, 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy induced cardiomyopathy 2 | Secondary efficacy endpoint: To compare the rate of cardiomyopathy between the experimental group and the control group in breast cancer patients receiving doxorubicin-containing chemotherapy with baseline normal heart function. The definition of cardiomyopathy is as follows.
|
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Inclusion Criteria:
Exclusion Criteria:
Subjects under the age of 19
Those who have implanted an intracardiac device (implantable defibrillator, pacemaker)
Hemodynamically unstable ventricular tachycardia confirmed
If you have QT prolongation syndrome or are receiving medication that increases QT interval
Patients with atrial fibrillation or those who have undergone defibrillation for atrial fibrillation within the last 3 months
In case of structural heart disease (congenital heart disease, valvular disease, etc.) and related surgery
Persons who have had coronary artery disease or a subsequent PCI or coronary artery bypass surgery
Those with symptoms of unstable angina requiring hospitalization
Persons suspected or diagnosed with cardiomyopathy due to causes other than chemotherapy
When life expectancy is less than 6 months
Pregnant women or those planning to become pregnant
Moderate or severe hepatic impairment (ex. Child-Pugh class B,C)
Creatinine clearance < 30mL/min
Patients judged to be inappropriate by other researchers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiwhan Kim, PhD | Contact | +82226505307 | kankadin@ewha.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Shinjeong Song, MD | EUMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kiwhan Kim | Recruiting | Seoul | Yangcheon Gu | 03168 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38385137 | Derived | Song S, Woo J, Kim H, Lee JW, Lim W, Moon BI, Kwon K. A prospective randomized controlled trial to determine the safety and efficacy of extracorporeal shock waves therapy for primary prevention of subclinical cardiotoxicity in breast cancer patients without a cardiovascular risk treated with doxorubicin. Front Cardiovasc Med. 2024 Feb 7;11:1324203. doi: 10.3389/fcvm.2024.1324203. eCollection 2024. |
| Label | URL |
|---|---|
| Extracorporeal shock waves protect cardiomyocytes from doxorubicin-induced cardiomyopathy by upregulating survivin via the integrin-ILK-Akt-Sp1/p53 axis | View source |
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IPD are not to be shared with other researchers.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 3months, 6months |
| D017437 |
| Skin and Connective Tissue Diseases |