[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625213":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":36,"interventions":49,"overallOfficials":27,"centralContacts":58,"locations":27,"responsibleParty":64,"collaborators":27,"id":66,"slug":27,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":27,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":27,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":27,"overallStatus":85,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":27},{"fullName":5,"class":6},"Nazarbayev University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":27},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Change in High-Sensitivity Troponin Levels","Change from baseline in serum high-sensitivity cardiac troponin levels as a marker of myocardial injury.","Baseline, 3 months, and 6 months",{"measure":14,"description":15,"timeFrame":12},"Change in NT-proBNP Levels","Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels as a marker of cardiac stress.",{"measure":17,"description":18,"timeFrame":12},"Change in Left Ventricular Ejection Fraction (LVEF)","Change from baseline in left ventricular ejection fraction measured by transthoracic echocardiography.",{"measure":20,"description":21,"timeFrame":12},"Change in Global Longitudinal Strain (GLS)","Change from baseline in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography.",[23],{"measure":24,"description":25,"timeFrame":26},"Safety and Tolerability of Grape Polyphenol Supplementation","Incidence and severity of adverse events related to the grape polyphenol concentrate and placebo during the intervention period.","Up to 3 months",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":33,"maskingDescription":27,"whoMasked":34},"SINGLE",[35],"PARTICIPANT",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Grape Polyphenol Concentrate","EXPERIMENTAL","Participants receive a grape polyphenol concentrate (QAYNAR) at a dose of 15 mL orally once daily for 3 months, starting with anthracycline- and\u002For trastuzumab-based chemotherapy.",[42],"Dietary Supplement: Grape Polyphenol Concentrate",{"label":44,"type":45,"description":46,"interventionNames":47},"Placebo","PLACEBO_COMPARATOR","Participants receive placebo (dark grape juice) at a dose of 15 mL orally once daily for 3 months, starting with anthracycline- and\u002For trastuzumab-based chemotherapy.",[48],"Other: Placebo (Dark Grape Juice)",[50,54],{"type":51,"name":38,"description":52,"armGroupLabels":53,"otherNames":27},"DIETARY_SUPPLEMENT","Grape polyphenol concentrate, 20 mg\u002FmL; participants take 15 mL orally once daily for 3 months starting with chemotherapy.",[38],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":27},"Placebo (Dark Grape Juice)","Placebo (dark grape juice); participants take 15 mL orally once daily for 3 months starting with chemotherapy.",[44],[59],{"name":60,"role":61,"phone":62,"phoneExt":27,"email":63},"Mohamad Aljofan, PhD","CONTACT","+77054448869","mohamad.aljofan@nu.edu.kz",{"type":65,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100625213",false,"NCT07419711","Grape Polyphenols for Prevention of Chemotherapy-Induced Cardiotoxicity","Cardioprotective Effects of Grape Polyphenols to Reduce Chemotherapy-Induced Cardiotoxicity in Breast Cancer Patients: A Randomized Pilot Study","Inclusion Criteria:\n\n* Female patients aged 30 to 75 years.\n* Histologically confirmed breast cancer.\n* Planned treatment with anthracycline- and\u002For trastuzumab-based chemotherapy.\n* High or very high risk of chemotherapy-induced cardiotoxicity (≥20%), based on clinical assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-3.\n* Ability to take oral study products.\n* Willingness to comply with study procedures and follow-up visits.\n* Written informed consent provided prior to any study procedures.\n\nExclusion Criteria:\n\n* ECOG performance status of 4.\n* Pre-existing severe cardiovascular disease that would interfere with study participation.\n* Permanent atrial fibrillation or other clinically significant arrhythmias.\n* Severe hepatic or renal impairment.\n* Active central nervous system tumors or metastases.\n* Uncontrolled arterial hypertension.\n* Acute gastrointestinal diseases that may impair absorption.\n* Known allergy or intolerance to grape products or study components.\n* Participation in another interventional clinical trial that may interfere with the outcomes of this study.","FEMALE","30 Years","75 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"NA","This pilot randomized clinical study aims to evaluate the cardioprotective effects of a grape polyphenol concentrate in patients receiving anthracycline- and\u002For trastuzumab-based chemotherapy. Adult patients at high or very high risk of chemotherapy-induced cardiotoxicity will be randomized to receive either a grape polyphenol concentrate or placebo for three months, starting with chemotherapy. Cardiac function and cardiotoxicity will be assessed using echocardiographic parameters and circulating biomarkers at baseline, 3 months, and 6 months.",[83,84],"Chemotherapy-induced Cardiotoxicity","Breast Cancer","NOT_YET_RECRUITING","2026-02-16",{"date":88,"type":89},"2026-02-19","ACTUAL",{"date":91,"type":77},"2026-02-09",{"date":93,"type":77},"2027-11-01",{"name":5,"class":6}]