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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Al demerdash hospital at oncology departement
RECRUITING
Cairo
Contact Information
Primary
Shimaa Nabil Abd elaziz Hassanein, bachelor
Shimaa.Nabil@pharm.helwan.edu.eg
+201115817090
Backup
Sara Mohamed Mohamed, Lecturer
Sara.abdel-motaleb@pharm.helwan.edu.eg
+201016903404
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
Active_comparator: Dapagliflozin group
Dapagliflozin group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) with dapagliflozin 10 mg tablet once daily.
No_intervention: Control group
Control group who consist of at least 20 breast cancer patients who receive 4 cycles of anthracyclines ( each cycle every 21 days ) only.
Related Therapeutic Areas
Sponsors
Leads: Helwan University

This content was sourced from clinicaltrials.gov