[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655625":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":22,"studyPopulation":13,"armGroups":23,"interventions":39,"overallOfficials":49,"centralContacts":55,"locations":65,"responsibleParty":85,"collaborators":13,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":13,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":13,"enrollmentInfo":98,"targetDuration":13,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":111,"whyStopped":13,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction.","LVEF from baseline (T0) to 6-month follow-up (T3), measured by 2D Speckle-Tracking Echocardiography.","6 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Prospective, randomized, parallel-group, active-controlled trial.","PREVENTION",{"masking":20,"maskingDescription":21,"whoMasked":13},"NONE","Open Label","Background \\& Rationale Anthracyclines, primarily Doxorubicin, induce cardiotoxicity through reactive oxygen species (ROS) accumulation, topoisomerase II-beta inhibition, mitochondrial dysfunction, and cardiomyocyte apoptosis.\n\n* Empagliflozin (SGLT2 inhibitor): Reduces oxidative stress, attenuates cardiac inflammation, improves myocardial energy bioenergetics, and prevents adverse left ventricular remodeling independently of glycemic status.\n* Metformin (AMPK activator): Restores autophagic flux, preserves mitochondrial membrane potential, reduces ROS production, and exhibits anti-tumor proliferation effects.\n* Gaps in Knowledge: While both drugs individually show promise against anthracycline-induced cardiotoxicity (AIC), direct head-to-head clinical trials comparing an SGLT2i versus Metformin during active anthracycline treatment are lacking.\n\n  3\\. Study Hypothesis\n* Primary Hypothesis: Prophylactic administration of Empagliflozin or Metformin significantly attenuates the subclinical decline in Left Ventricular Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) compared to standard care in women receiving doxorubicin.\n* Secondary Hypothesis: Empagliflozin demonstrates superior reduction in cardiac biomarker elevation (hs-cTnI, NT-proBNP) and microvascular strain compared to Metformin.\n\n  4\\. Study Objectives Primary Objective To compare the changes in left ventricular systolic function (measured via baseline to 6-month Echocardiographic GLS and LVEF) among the Empagliflozin group, Metformin group, and Control group.\n\nSecondary Objectives\n\n1. Evaluate subclinical myocardial injury via serum biomarkers: High-sensitivity Cardiac Troponin I (hs-cTnI) and N-terminal pro-B-type Natriuretic Peptide (NT-proBNP).\n2. Monitor metabolic profiles (fasting blood glucose, HbA1c, and lipid profile).\n3. Evaluate patient-reported outcomes (Karnofsky Performance Scale \u002F Minnesota Living with Heart Failure Questionnaire).\n4. Compare the safety profile, chemotherapy completion rates, and short-term oncologic response (pathological Complete Response in neoadjuvant settings).\n5. Methodology \\& Study Design 5.1 Study Settings and Design\n\n   * Design: Prospective, randomized, parallel-group, active-controlled trial.\n   * Setting: Tanta Oncology Hospital \u002F Cardio-Oncology Center. 5.2 Participant Eligibility Criteria\n\nInclusion Criteria:\n\n1. Adult females (≥18 years) with histologically confirmed breast cancer.\n2. Scheduled to receive doxorubicin-based chemotherapy regimens (e.g., AC regimen: Doxorubicin + Cyclophosphamide every 2 or 3 weeks for 4 cycles).\n3. Baseline LVEF ≥ 55 on transthoracic echocardiography with normal baseline GLS.\n4. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m2\n5. Written informed consent provided.\n\nExclusion Criteria:\n\n1. Prior exposure to anthracyclines, mediastinal radiation, or anti-HER2 therapy.\n2. Pre-existing heart failure, coronary artery disease, or LVEF $\\\u003C 55\\\\%$.\n3. Uncontrolled Type 2 Diabetes Mellitus (HbA1c $\\> 8.5\\\\%$) or Type 1 Diabetes Mellitus.\n4. Severe renal impairmet (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2) or hepatic dysfunction.\n5. History of recurrent Urinary Tract Infections (UTIs), genital mycotic infections, or ketoacidosis (for Empagliflozin safety).\n6. Hypersensitivity to Empagliflozin or Metformin.",[24,28,34],{"label":25,"type":26,"description":27,"interventionNames":13},"Arm A (Control)","NO_INTERVENTION","Standard oncologic care without cardioprotective intervention followed concurrently for 12 weeks",{"label":29,"type":30,"description":31,"interventionNames":32},"Arm B (Empaglflozin)","ACTIVE_COMPARATOR","Empagliflozin 10 mg orally once daily initiated 1 week prior to chemotherapy; continued for 12 weeks",[33],"Drug: Empagliflozin (EMPA)",{"label":35,"type":30,"description":36,"interventionNames":37},"Arm C (Metformin)","Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) initiated 1 week prior to chemotherapy; continued for 12 weeks",[38],"Drug: Metformin",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"DRUG","Empagliflozin (EMPA)","Intervention group: A group in which patients receive Empagliflozin drug at a dose of 10 mg once in the day, or along with chemotherapy.",[29],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":13},"Metformin","Metformin 500 mg orally twice daily (escalated to 1000 mg twice daily as tolerated) Initiated 1 week prior to chemotherapy; continued for 12 weeks",[35],[50,53],{"name":51,"affiliation":5,"role":52},"Mohamed Abdelhamid Almeldein, Professor","STUDY_DIRECTOR",{"name":54,"affiliation":5,"role":52},"Mohamed Abdelhamid Alameldein, Professor",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Mai Aboelyazed El-Gebaly, Associate Lecturer","CONTACT","+0201061412257","020","dr.mai.elgebaly@gmail.com",{"name":63,"role":58,"phone":64,"phoneExt":60,"email":61},"Mai Aboelyazed Elgebaly, Associate Lecturer","+201115064114",[66],{"facility":5,"status":13,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Tanta","Elgharbeya","GHR","Egypt","EG",{"type":73,"coordinates":74},"Point",[75,76],31.00192,30.78847,{"lat":76,"lon":75},[79,81,83],{"name":57,"role":58,"phone":80,"phoneExt":60,"email":61},"010-6141-2257",{"name":63,"role":58,"phone":82,"phoneExt":60,"email":61},"011-1506-4114",{"name":54,"role":84,"phone":13,"phoneExt":13,"email":13},"SUB_INVESTIGATOR",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mai Abo Elyazeed Hassan Hamouda","Associate Lecturer","100655625","phase-3-cardioprotective-effect-of-empagliflozin-in-breast-cancer-patients-100655625",false,"NCT07815808","Cardioprotective Effect of Empagliflozin in Breast Cancer Patients","Effects of Empagliflozin Versus Metformin in Women With Breast Cancer Receiving Doxorubicin-Based Chemotherapy: A Prospective Randomized Controlled Cardio-Oncology Trial","Inclusion Criteria:\n\n1. Adult females (≥18 years) with histologically confirmed breast cancer.\n2. Scheduled to receive doxorubicin-based chemotherapy regimens (e.g., AC regimen: Doxorubicin + Cyclophosphamide every 2 or 3 weeks for 4 cycles).\n3. Baseline LVEF ≥ 55 on transthoracic echocardiography with normal baseline GLS.\n4. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m2\n5. Written informed consent provided\n\nExclusion Criteria:\n\n1. Prior exposure to anthracyclines, mediastinal radiation, or anti-HER2 therapy.\n2. Pre-existing heart failure, coronary artery disease, or LVEF $\\\u003C 55\\\\%$.\n3. Uncontrolled Type 2 Diabetes Mellitus (HbA1c $\\> 8.5\\\\%$) or Type 1 Diabetes Mellitus.\n4. Severe renal impairmet (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2) or hepatic dysfunction.\n5. History of recurrent Urinary Tract Infections (UTIs), genital mycotic infections, or ketoacidosis (for Empagliflozin safety).\n6. Hypersensitivity to Empagliflozin or Metformin.","FEMALE","18 Years",{"count":99,"type":100},150,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","Background: Doxorubicin (DOX) remains a cornerstone in adjuvant and neoadjuvant therapy for breast cancer, but its utility is hindered by dose-dependent cardiotoxicity. Both SGLT2 inhibitors (Empagliflozin) and Biguanides (Metformin) have demonstrated off-target cardioprotective and metabolic properties in preclinical and clinical settings.\n\nObjective: To compare the cardioprotective efficacy, safety, and metabolic\u002Foncologic outcomes of Empagliflozin versus Metformin in non-diabetic or controlled-diabetic women with breast cancer undergoing doxorubicin-based chemotherapy.\n\nDesign: Prospective, 3-arm, open-label (or double-blind), randomized controlled clinical trial (RCT).\n\nDuration: 18 months",[106],"Empgliflozin Cardioprotective Effect",[108,109,110],"Empagliflozin","Cardioprotection","Dox Cardiotoxicity","NOT_YET_RECRUITING","2026-09-07",{"date":114,"type":115},"2026-09-11","ACTUAL",{"date":117,"type":100},"2026-10-01",{"date":119,"type":100},"2028-12-31",{"name":5,"class":6},1]