Clinical trial · Interventional
Pilot Study to Evaluate the Prevention and Safety of Doxorubicin-induced Cardiomyopathy Using Extracorporeal Shock Waves
Single-center, Randomized, Prospective Controlled Pilot Study to Evaluate the Prevention and Safety of Doxorubicin-induced Cardiomyopathy Using Extracorporeal Shock Waves in Breast Cancer Patients Using Doxorubicin Anticancer Drugs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extracorporeal shock waves | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Group not using drugs used for the prevention of cardiomyopathy caused by doxorubicin, including extracorporeal shock wave
- type
- EXPERIMENTAL
- label
- ESWT treatment group
- description
- Group receiving extracorporeal shock wave therapy
- interventionNames
- Device: Extracorporeal shock waves
Primary outcomes (1)
- measure
- Chemotherapy induced cardiomyopathy
- timeFrame
- 3months, 6months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Breast cancer patients receiving doxorubicin chemotherapy (for patients with operable breast cancer who receive doxorubicin with neoadjuvant or adjuvant chemotherapy) 2. 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 3. Those with a left ventricular ejection fraction of 50% or more at screening Exclusion Criteria: 1. Subjects under the age of 19 2. Those who have implanted an intracardiac device (implantable defibrillator, pacemaker) 3. Hemodynamically unstable ventricular tachycardia confirmed 4. If you have QT prolongation syndrome or are receiving medication that increases QT interval * Antiarrhythmics class IA; quinidine, procainamide * Antiarrhythmics class III; amiodarone, sotalol 5. Patients with atrial fibrillation or those who have undergone defibrillation for atrial fibrillation within the last 3 months 6. In case of structural heart disease (congenital heart disease, valvular disease, etc.) and related surgery 7. Persons who have had coronary artery disease or a subsequent PCI or coronary artery bypass surgery 8. Those with symptoms of unstable angina requiring hospitalization 9. Persons suspected or diagnosed with cardiomyopathy due to causes other than chemotherapy 10. When life expectancy is less than 6 months 11. Pregnant women or those planning to become pregnant 12. Moderate or severe hepatic impairment (ex. Child-Pugh class B,C) 13. Creatinine clearance \< 30mL/min 14. Patients judged to be inappropriate by other researchers
References
Publications (1)
- DERIVEDSong 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. PMID 38385137