RecruitingPhase 2NCT06427226

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

Clinical Study to Evaluate the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients

Sponsor

Tanta University

Enrollment

46 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Doxorubicin Induced Cardiomyopathy

Summary

This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria10

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.