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

NCT05584163 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-06-02

No results posted yet for this study

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

Interventions

DEVICE

Extracorporeal shock waves

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.

Sponsors & Collaborators

  • Ewha Womans University Mokdong Hospital

    lead OTHER

Principal Investigators

  • Shinjeong Song, MD · EUMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584163 on ClinicalTrials.gov