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Recruiting Phase 4

Cardiotoxicity in Breast Cancer Patients

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About this study

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.

Condition
Breast Cancer
Tested
Dapagliflozin 10mg Tab
Sponsor
Helwan University

Who can join

Age
18 to 60 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Maximum age: 60 years
  • Study condition: Breast Cancer
  • 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 7

  • 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

1 site, 1 recruiting

Al demerdash hospital at oncology departement

Cairo, Cairo Governorate, Egypt

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.