Protocol summary
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Study aim
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Evaluation of the effectiveness of Empagliflozin in preventing doxorubicin-induced cardiac toxicity in patients with breast cancer receiving AC regimen
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Design
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The clinical trial has a control group with parallel groups that is performed in two blind, randomized, phase 3 and on 64 patients. Block randomization method is used for randomization
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Settings and conduct
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This study was performed at the Imam Khomeini Hospital Cancer Institute, Tehran University of Medical Sciences, with the aim of investigating the possibility of prescribing Empagliflozin to prevent the occurrence of doxorubicin-induced cardiac toxicity in breast cancer patients and on 64 patients who are in two groups. Patients in the two groups are compared in terms of criteria including: blood levels of cardiac biomarkers and echocardiographic results.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: People who have recently been definitively diagnosed with breast cancer and are candidates for a chemotherapy regimen containing doxorubicin.
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Intervention groups
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Patients are divided into two groups. In the first group, Empagliflozin is prescribed with a chemotherapy regimen and in the second group, the same chemotherapy regimen is prescribed with a Placebo
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Main outcome variables
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Echocardiographic variables including: EF and GLS
Cardiac biomarkers including Troponin I and NT-proBNP
General information
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Reason for update
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The changes are as follows:
1- In the secondary outcome section, in consultation with the supervisor professors, the CPK-MB test was replaced with the NT-proBNP test, which is much more accurate for heart failure.
2- In the intervention groups section, Actoverco Company was changed to Dr. Abidi Pharmaceuticals.
Thank you for your attention.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231014059713N1
Registration date:
2023-11-18, 1402/08/27
Registration timing:
prospective
Last update:
2025-05-04, 1404/02/14
Update count:
1
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Registration date
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2023-11-18, 1402/08/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-22, 1402/09/01
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Expected recruitment end date
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2024-09-21, 1403/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of empagliflozin in prevention of Doxorubicin-induced cardiotoxicity in patients with breast cancer and receiving AC regimen (Cyclophosphamide + Doxorubicin): a randomized, placebo-controlled, double-blind trial
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Public title
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Efficacy of empagliflozin in prevention of Doxorubicin-induced cardiotoxicity in patients with breast cancer
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
A known case of breast cancer and candidate for receiving AC regimen
Signing a written informed consent to participate in the study
Patient age ≥ 18
Ability to take oral medicine
ECOG performance status less than or equal to 2
Exclusion criteria:
A history of breast cancer or a history of receiving chemotherapy regimen containing anthracycline or other chemotherapy drugs causing cardiomyopathy before entering the study
Inability to assess left ventricular (LV) function
Previous history of chest radiation therapy
Evidence of heart failure or left ventricular dysfunction based on echocardiography
Diagnosis or history of cardiomyopathies
Significant coronary artery disease (history of coronary stenting or stenosis based on previous angiography, history of known IHD or MI)
Severe valvular heart disease
Cardiac arrhythmia such as atrial fibrillation
Symptomatic hypotension or blood pressure less than 90 mmHg at the first visit
Liver enzymes more than 3 times ULN before entering the study
Significant renal failure (GFR less than 20 ml/min/1.73m2 with CKD-EPI formula) or need for dialysis
Simultaneous use of other drugs that can affect parameters of the study (such as ACEi, ARB, beta blockers)
Diabetes
Pregnancy
Breastfeeding
Hypersensitivity to SGLT2 inhibitor drugs
History of treatment with SGLT2 inhibitors during the last 3 months before the start of the study
Participation in other clinical studies simultaneously
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Age
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From 18 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomly assigned to two groups of intervention (receiving chemotherapy regimen + empagliflozin) and control (receiving chemotherapy regimen + placebo) by using block randomization. This is a double-blinded trial {the patient, researcher (student) and the doctors} and the randomization will be performed by the project executor based on double or quadruple random tables and on each box, a number will be registered, the contents of which will be unknown, and will be given to the researcher and then to the patient.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants in the study, the physician who introduced them to the research team, the cardiologist who is responsible for measuring echocardiographic parameters of patients in both groups, and the laboratory staff who are responsible for measuring cardiac biomarkers in patients and the student who makes the arrangements (as a researcher) are blinded in this study. The project executor by using block randomization method (using two or four tables), assign a number randomly to each box containing the medicine or placebo, that is given to the researcher and the patient.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-11-11, 1402/08/20
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Ethics committee reference number
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IR.TUMS.TIPS.REC.1402.102
Health conditions studied
1
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Description of health condition studied
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Breast cancer
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ICD-10 code
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C50
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ICD-10 code description
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Malignant neoplasm of breast
2
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Description of health condition studied
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Drug-induced cardiomyopathy
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ICD-10 code
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I42.7
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ICD-10 code description
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Cardiomyopathy due to drug and external agent
Primary outcomes
1
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Description
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LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction.
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Timepoint
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Once at the beginning and once a week after the last chemotherapy session
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Method of measurement
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Using echocardiography performed by a cardiologist
2
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Description
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GLS (Global longitudinal strain): A sensitive criterion used by echocardiography to measure myocardial deformity and left ventricular contractile strength and can aid in the early diagnosis of cardiotoxicity. A decrease of more than 15% compared to the beginning or an absolute value of -19% after the start of anthracyclines is associated with a significant increase in the risk of future LVEF reduction.
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Timepoint
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At the beginning and one week after the last chemotherapy session
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Method of measurement
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Echocardiography by a cardiologist
Secondary outcomes
1
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Description
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Troponin I: One of the three types of troponin present in the body that is more specific to the myocardium of the heart and as a marker of the heart, can help diagnose myocardial damage. This enzyme increases within a few hours after heart damage and can last for a long time. Remain in my head for 10-14 days.
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Timepoint
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Once at the beginning and twice at one week after the second and last session of chemotherapy
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Method of measurement
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Blood sampling and blood level measurement by laboratory
2
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Description
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NT-proBNP: It is one of the types of natriuretic peptides that indicates the filling pressure inside the heart and the stress of the walls of the ventricles, which is used to diagnose heart failure.
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Timepoint
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Once at the beginning and twice at one week after the second and last session of chemotherapy.
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Method of measurement
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Blood sampling and blood level measurement by laboratory
Intervention groups
1
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Description
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Intervention group: A group in which patients receive Empagliflozin drug produced by abidi pharmaceutical at a dose of 10 mg once in the day along with chemotherapy. The patient will receive this drug from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen.
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Category
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Prevention
2
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Description
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Control group: A group in which patients receive Placebo produced by abidi pharmaceutical once in the day along with chemotherapy. The patient will receive placebo from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is not necessary
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Final proposal report
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When the data will become available and for how long
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One year
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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For other researchers to use the results of the data
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From where data/document is obtainable
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To the main executor of the project
Dr. Ehsan Shabani
Email: eshabani@razi.tums.ac.ir
Mobile: 09014462400
Address: No. 1, Nahid Ave., Marzdaran Blvd., Ashrafi Esfahani Expy
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What processes are involved for a request to access data/document
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Send email to the main executor of the project
Email: eshabani@razi.tums.ac.ir
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Comments
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