Pilot Study to Evaluate the Prevention and Safety of Doxorubicin-induced Cardiomyopathy Using Extracorporeal Shock Waves

NCT05584163 | Unknown DMC

• 1 other identifier: 2020-12-044-012
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Chemotherapy induced cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Chemotherapy induced cardiomyopathy 2

  3months, 6months

Study Arms (2)

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

Device: Extracorporeal shock waves

Interventions

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.

ESWT treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Antiarrhythmics class IA; quinidine, procainamide
• Antiarrhythmics class III; amiodarone, sotalol
• 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

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

Study Sites (1)

Kiwhan Kim

Seoul, Yangcheon Gu, 03168, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 38385137 DERIVED

Related Links

• Extracorporeal shock waves protect cardiomyocytes from doxorubicin-induced cardiomyopathy by upregulating survivin via the integrin-ILK-Akt-Sp1/p53 axis

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shinjeong Song, MD

  EUMC

  STUDY DIRECTOR

Central Study Contacts

Kiwhan Kim, PhD

CONTACT

+82226505307; kankadin@ewha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: October 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)