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

Status: Unknown
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Kiwhan Kim
RECRUITING
Seoul
Contact Information
Primary
Kiwhan Kim, PhD
kankadin@ewha.ac.kr
+82226505307
Time Frame
Start Date: 2020-10-01
Completion Date: 2023-06
Participants
Target number of participants: 72
Treatments
No_intervention: Control group
Group not using drugs used for the prevention of cardiomyopathy caused by doxorubicin, including extracorporeal shock wave
Experimental: ESWT treatment group
Group receiving extracorporeal shock wave therapy
Sponsors
Leads: Ewha Womans University Mokdong Hospital

This content was sourced from clinicaltrials.gov