Evaluation of protective effects of bisoprolol against anthracycline-induced cardiomyopathy
Design
In this randomized double-blind study, which is a trial phase 3, We enroll 90 patients with breast cancer recommended for treatment with adriamycin and cyclophosphamide. Patients randomly bisoprolol (n = 45) and placebo (n = 45) daily.Excel software rand function is used for randomization.
Settings and conduct
Prophylactic use of bisoprolol for reducing cardiomyopathy induced by anthracycline is the field of study that done in Shariati hospital.We identify brest cancer patients who are candidates for anthracycline chemotherapy. In the intervention group, bisoprolol is administered orally at a dose of 2.5 mg and also placebo in the control group for 7 consecutive days before chemotherapy in the morning.
Both bisoprolol and placebo last for 6 months.Echocardiography is performed at the beginning , three and 6 months after chemotherapy.The data is analyzed.The data collection and analysis stage, will be done by the project manager.The patient, the executor of the plan & supervisor, are not aware of the contents of the packages. This study is two-blinded.
Participants/Inclusion and exclusion criteria
Inclusion:
1.Patients with breast cancer 2.Patients treated with anthracyclines 3.Patients who do not have chronic blood pressure, diabetes
Exclusion:
1. Patient dissatisfaction 2. A patient who has a contraindication to the use of beta-blockers 3. History of radiation or chemotherapy to the chest 4.Receiving beta-blocker drugs
Intervention groups
the intervention group, bisoprolol administer at a dose of 2.5 mg and in the control group, placebo administer orally for 7 consecutive days before chemotherapy in the morning & continues for 6 months.
Main outcome variables
left ventricular end diastolic & systolic volume/left ventricular end diastolic& systolic diamater/global longitudinal strain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130701013828N8
Registration date:2021-10-04, 1400/07/12
Registration timing:prospective
Last update:2021-10-04, 1400/07/12
Update count:0
Registration date
2021-10-04, 1400/07/12
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Protective effects of Bisoprolol against anthracycline-induced cardiomyopathyin in breast cancer patient
Public title
Protective effects of Bisoprolol against anthracycline-induced cardiomyopathy in breast cancer patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer
Patients with indication for AC (doxorubicin hydrochloride (Adriamycin) and cyclophosphamide) regimen for chemotherapy
Patients agreement
Exclusion criteria:
Patients non compliance
Patients who have cardiovascular problems
Have previously undergone chest radiotherapy
Patients who have allergy to Bisoprolol
Patients currently taking beta-blockers
Patients who have contraindicated for use beta blockers.
Age
From 25 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
45
In intervention group 45 individuals and in control group 45 individuals become participate.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study use block randomization and unit of randomization is individual. Block randomization divides patients into M blocks of size 2N, so that in each block N patients are assigned A and patients N are assigned to B. The block is then selected randomly.The size of the block is not stated in the study so that researchers are blind to it.Rand Excel function randomization tool is helpful.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are treated with medication packages pre-determined by the study supervisor. Drug packages are exactly the same in shape and the patient and the project facilitator are not aware of the contents of the packages. The executor and his assistant are done who are not aware of the contents of the packages; In the data analysis stage, the analysis will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the group of patients (group 1 or 2) will be identified for data analysis; Therefore, the study is three-blind and the contents of the two drug groups are not clear from the stage of patient entry into the study to the study, data collection and analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
School of Medicine ,Isfahan University,Azad Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1400.058
Health conditions studied
1
Description of health condition studied
chemotherapy induced cardiomyopathy in breast cancer patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
LVEDV(left ventricular end diastolic volume)
Timepoint
The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention.
Method of measurement
Specialized echocardiography
2
Description
(GLS)global longitudinal strain
Timepoint
The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention.
Method of measurement
Specialized echocardiography
3
Description
LVESD(left ventricular end systolic diameter)
Timepoint
The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention.
Method of measurement
Specialized echocardiography
4
Description
LVEDD(left ventricular end diastolic diameter)
Timepoint
The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention.
Method of measurement
Specialized echocardiography
5
Description
LVESV(left ventricular end systolic volume)
Timepoint
The first measurement is before the start of chemotherapy and before the intervention, then three months and six months after chemotherapy and during the intervention.
Method of measurement
Specialized echocardiography
Secondary outcomes
1
Description
cardiotoxicity
Timepoint
before chemotherapy and end of chemotherapy
Method of measurement
Echocardiography
2
Description
Dizziness
Timepoint
after start of drug
Method of measurement
Ask patient
Intervention groups
1
Description
Intervention group: 2.5 mg Bisoprolol tablets from Abidi company are taken daily from one week before the start of chemotherapy until the end of the chemotherapy course
Category
Prevention
2
Description
Control group: Placebo is given to the control group like intervention group from one week before the start of chemotherapy until the end of the chemotherapy course