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Cardiotoxicity in Breast Cancer Patients

RECRUITINGPhase 4Sponsored by Helwan University
Actively Recruiting
PhasePhase 4
SponsorHelwan University
Started2024-09-10
Est. completion2025-10
Eligibility
Age18 Years – 60 Years
Healthy vol.Accepted

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

Age: 18 Years – 60 YearsHealthy volunteers accepted
Inclusion Criteria:

1. patients with pathologically proved invasive breast carcinoma.
2. Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines.
3. Renal function (eGFR \> 30 mL/minute per 1.73 m2 )
4. LVEF is more than 50 %
5. Age ≥ 18 and ≤ 60 years old

Exclusion Criteria:

1. patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction.
2. Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens
3. pregnant or breastfeeding patients
4. patients receiving any other cardiotoxic agents.
5. Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
6. Mediastinal irradiation including heart.
7. Refusal to sign the written informed consent.

Conditions2

Breast CancerCancer

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