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โ† Trials
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Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity

RecruitingPhase 2Ages 18 Years - 65 YearsFemaleTanta University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years old. * Chemo-naรฏve 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 โ‰ฅ55%. * Adequate baseline hematologic values (absolute neutrophilic count โ‰ฅ 1.5 ร—109/L, platelet count โ‰ฅ 90 ร— 109/L and hemoglobin level โ‰ฅ 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.
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What it tests

  • Dapagliflozin 10mg Tab
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Where

1 site
Medical Research Institute
Alexandria, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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