Cardiotoxicity in Breast Cancer Patients
Recruiting · NCT06491680 · Interventional (participants receive a specific treatment) · Lead sponsor: Helwan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- patients with pathologically proved invasive breast carcinoma.
- Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines.
- Renal function (eGFR \> 30 mL/minute per 1.73 m2 )
- LVEF is more than 50 %
- Age ≥ 18 and ≤ 60 years old
Exclusion criteria
- patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction.
- Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens
- pregnant or breastfeeding patients
- patients receiving any other cardiotoxic agents.
- Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
- Mediastinal irradiation including heart.
- Refusal to sign the written informed consent.
Where it is running
1 location listed.
- Al demerdash hospital at oncology departement - Cairo, Cairo Governorate, Egypt