RecruitingPhase 4NCT06491680

Cardiotoxicity in Breast Cancer Patients

Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients

Sponsor

Helwan University

Enrollment

40 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug. Aim of the study: Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity. The main questions it aims to answer are: 1. Does the drug lower the cardiotoxicity which induced by anthracyclines? 2. What medical problems do participants have when taking dapagliflozin drug? Treatment 1. Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination. 2. Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring heart health in breast cancer patients who are receiving anthracycline chemotherapy (a type of chemotherapy known to have potential heart side effects). Researchers want to detect signs of heart damage early using echocardiograms (heart ultrasounds) and blood tests. **You may be eligible if...** - You are 18 to 60 years old with confirmed invasive breast cancer - You are scheduled to receive anthracycline-based chemotherapy (before or after surgery) - Your heart function (ejection fraction) is above 50% - Your kidney function is adequate **You may NOT be eligible if...** - You have a pre-existing heart condition that makes anthracyclines unsafe (like heart failure, arrhythmia, or prior heart attack) - You have previously received anthracycline or other heart-toxic chemotherapy - You are pregnant or breastfeeding - You have diabetic ketoacidosis or are currently taking other heart-toxic medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin 10mg Tab

Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose. taken orally, once daily. Started from 5 to 7 days before the first cycle of anthracyclines till the end of last anthracycline dose.

Locations(1)

Al demerdash hospital at oncology departement

Cairo, Cairo Governorate, Egypt

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NCT06491680

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