Trial Title:
Pilot Study to Evaluate the Prevention and Safety of Doxorubicin-induced Cardiomyopathy Using Extracorporeal Shock Waves
NCT ID:
NCT05584163
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cardiomyopathies
Conditions: Keywords:
Chemotherapy induced cardiomyopathy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Extracorporeal shock waves
Description:
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.
Arm group label:
ESWT treatment group
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.
Detailed description:
1. Extracorporeal shock wave therapy cycle
- For breast cancer patients using doxorubicin as the main anticancer agent, 1
cycle of extracorporeal shock wave therapy was performed every 2 cycles of
chemotherapy.
- The extracorporeal shock wave therapy is targeted to the existing refractory
angina pectoris patients and is based on the energy used in patients with
ischemic heart disease without serious side effects. The treatment is performed
3 times a week in 1 cycle, 200 shots per spot. , a shock wave of 0.09mJ/mm2
energy was applied to 40-60 spots (8,19,20)
- Conventional chemotherapy is performed every 3 weeks, and the dose of
doxorubicin used per session is 40-60 mg/m2, and considering the cumulative
dose, chemotherapy is performed on average 6-8 times. Therefore, extracorporeal
shock wave therapy is performed every 6 weeks, and a total of 3 to 4 times.
- It is expected that factors affecting efficacy will be controlled by targeting
patients with the same carcinoma, the same chemotherapy, and no underlying
heart disease. Since the cumulative doxorubicin dose can be received from a
minimum of 60mg/m2 to a maximum of 400mg/m2, the cumulative dose of doxorubicin
in the control and experimental groups should be divided into sections to
further analyze the cardiomyopathy incidence rate and echocardiographic
indicators.
- Extracorporeal shock wave therapy position and posture The extracorporeal shock
wave probe is placed at the position where the apical view of the
echocardiogram is taken, and the patient's posture is supine or lateral
position. When extracorporeal shock wave therapy is performed in the following
locations, the entire cardiac muscle can be included.
2. It was assumed that the incidence of cardiomyopathy in patients receiving
extracorporeal shock wave therapy was low. Cardiomyopathy is defined as ① a decrease
in the absolute value of left ventricular ejection fraction by 10% or more or ② 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.
3. Observational items/clinical examination items and observational examination method
Basic information: Acquired at the time of clinical research registration
- Age, gender, height, weight, BMI, systolic diastolic blood pressure, pulse
clinical information
- Clinical information 1: Acquired at the time of clinical research registration
Accompanying diseases (hypertension, diabetes, dyslipidemia, chronic kidney
disease, etc.), past acute reaction
- Clinical information 2: Acquired at the time of clinical study registration and
every echocardiogram follow-up Breast cancer stage, doxorubicin dose used for
chemotherapy, chemotherapy cycle medications taken within the past 4 weeks
(including current medications);
- Diagnostic test results (Creatinie Kinase (CK), Creatine Kinase-MB (CK-MB),
Troponin T (TnT), N-terminal pro-Brain natriuretic peptide (NT-proBNP), compete
blood count (CBC), Chemistry) ,
- New York Heart Association (NYHA) classiciation - Class 1,2,3,4; It is obtained
by dividing into Class 1, 2, 3, and 4 through a questionnaire about the
patient's subjective symptoms, and is obtained through a questionnaire at the
time of clinical study registration and every echocardiogram follow-up.
- Electrocardiogram (EKG). Chest X-ray (CXR) Echocardiographic parameters:
Acquired at the time of clinical study registration and at each
echocardiographic follow-up.
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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Kiwhan Kim
Address:
City:
Seoul
Zip:
03168
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Shinjeong Song, MD
Phone:
01087889871
Email:
allaboutsj@naver.com
Start date:
October 1, 2020
Completion date:
June 2023
Lead sponsor:
Agency:
Ewha Womans University Mokdong Hospital
Agency class:
Other
Source:
Ewha Womans University Mokdong Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05584163
https://www.nature.com/articles/s41598-019-48470-0
