[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563960":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":35,"responsibleParty":53,"collaborators":17,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":17,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":38,"whyStopped":17,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Protein- and Calorie restriction group","This group will receive the dietary intervention.",[12],"Other: Protein- and Calorie restriction",{"label":14,"type":15,"description":16,"interventionNames":17},"Control Group","NO_INTERVENTION","This group will not receive any intervention.",null,[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":17},"Protein- and Calorie restriction","The intervention consists of 30% calorie and 70% protein restriction, based on their daily nutritional intake. The protein and calorie restriction will be given in the form of Scandishake from Nutricia. These are ready available and easy to tailor to the caloric and protein need of each individual study subject.",[9],[24],{"name":25,"affiliation":5,"role":26},"Franny Jongbloed, MD\u002FPhD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":17,"email":32},"Sheraz Ditta, PharmD","CONTACT","+31639462883","s.ditta@erasmusmc.nl",{"name":25,"role":30,"phone":17,"phoneExt":17,"email":34},"f.jongbloed@erasmusmc.nl",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Erasmus MC","RECRUITING","Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],4.47917,51.9225,{"lat":48,"lon":47},[51,52],{"name":29,"role":30,"phone":31,"phoneExt":17,"email":17},{"name":25,"role":30,"phone":17,"phoneExt":17,"email":34},{"type":26,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Franny Jongbloed","Principal Investigator","100563960","dietary-restriction-to-prevent-cardiotoxicity-in-breast-cancer-patients-100563960",false,"NCT06622954","Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients","Protein and Calorie Restriction as Treatment for Prevention of Cardiotoxicity in Women Receiving Chemotherapy.","PROTECT-COR","Inclusion Criteria:\n\n* women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment;\n* age between 18 and 75 years;\n* written informed consent;\n* body mass index ≥ 19.\n\nExclusion Criteria:\n\n* Allergic to any of the ingredients of the diet;\n* Known history of cardiac dysfunction;\n* Severe morbidity with the inability to receive anticancer treatment.\n* Participation in another clinical trial with an intervention arm (database and\u002For biobank studies excluded);\n* Pregnant women\n* Previous treatment with anthracycline\n* Estrogen receptor positive status","FEMALE","18 Years","75 Years",{"count":68,"type":69},32,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is:\n\nWhat are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer.\n\nResearchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups.",[75,76],"Cardiotoxicity","Breast Cancer",[78,79,80,81,82,83,84,75],"Dietary restriction","Diet","Anthracyclines","High sensitivity troponin T","HsTnT","Oxidative stress","Breast cancer","2024-09-30",{"date":87,"type":88},"2024-10-02","ACTUAL",{"date":90,"type":88},"2023-05-10",{"date":92,"type":69},"2026-05",{"name":5,"class":6},1]