Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity

Launched by TANTA UNIVERSITY · May 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Dapagliflozin to help protect the heart from damage caused by a cancer treatment known as doxorubicin. Doxorubicin is often used for treating breast cancer, but it can sometimes harm the heart. The trial will involve women aged 18 to 65 who have been diagnosed with early-stage breast cancer and who are planning to receive at least four cycles of doxorubicin. Participants must also have good heart function before starting the treatment.

If you or a loved one are interested in participating, you should know that you will need to meet certain health criteria, such as having a specific level of heart function and not having any recent heart problems. Participants will receive close monitoring during the trial to ensure their safety. This trial is not yet recruiting, so if you think you might be eligible, it’s a good idea to talk to your healthcare provider for more information about potential participation.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years old.
• • Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
• • Patients intended to receive at least 4 cycles of doxorubicin or more.
• • Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
• • Echocardiographic LVEF ≥55%.
• • Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
• • Patients with adequate liver function and adequate renal function.
• • Signed informed consent to participate in the study.
• Exclusion Criteria:
• • Age \<18 years old and \>65 years old.
• • Patients with prior exposure to anthracyclines within the last 6 months.
• • Patients with evidence of metastasis at initial assessment.
• • Treatment with any SGLT-2 inhibitors for 6 months prior to the screening.
• • Patients taking any other cardioprotective medications.
• • Pregnancy and breast feeding.
• • Alcohol abuse.
• • History of heart failure or LVEF \<50%.
• • Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.
• • Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.