[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564033":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":25,"responsibleParty":43,"collaborators":46,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Aarhus University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Early breast cancer patients initiating endocrine therapy",null,"Patients with estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy (either tamoxifen or aromatase inhibitors).",[13],{"name":14,"affiliation":5,"role":15},"Signe Borgquist, Clinical Chair Professor, Ph.D","PRINCIPAL_INVESTIGATOR",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Lærke S Nissen, BS.c., Research Year Student","CONTACT","(+45) 61 11 29 28","laenis@rm.dk",{"name":14,"role":19,"phone":23,"phoneExt":10,"email":24},"(+45) 91 16 72 94","Signe.borgquist@auh.rm.dk",[26],{"facility":27,"status":10,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Department of Oncology, Aarhus University Hosptial","Aarhus N","Central Jutland","8200","Denmark","DK",{"type":34,"coordinates":35},"Point",[36,37],10.17317,56.20367,{"lat":37,"lon":36},[40,41],{"name":14,"role":19,"phone":23,"phoneExt":10,"email":24},{"name":42,"role":19,"phone":20,"phoneExt":10,"email":21},"Lærke S Nissen, BS.c., Research year student",{"type":15,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Signe Borgquist","Chair Professor, Senior Consultant, PhD",[47],{"name":48,"class":6},"Danish Cancer Society","100564033","early-changes-in-metabolic-health-in-breast-cancer-patients-initiating-endocrine-therapy-100564033",false,"NCT06623903","Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy","Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study","EMETA","Inclusion Criteria:\n\n* Age ≥18 years\n* Invasive ER+ breast cancer\n* No diabetes treatment\n* Planned for initiation of any adjuvant endocrine therapy.\n\nExclusion Criteria:\n\n* Pregnancy or lactation,\n* Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.","ALL","18 Years",{"count":60,"type":61},112,"ESTIMATED","3 Months","OBSERVATIONAL","This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy. Furthermore, how these changes are affected by estrogen level, treatment type, and patient characteristics. The hypothesis is, that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months. This includes increased BMI (Body Mass Index), waist- and hip circumference, blood pressure, blood sugars, and lipids compared to when the patients initiate antihormone therapy. Concurrently, estradiol levels are expected to decrease. An estimated 112 patients initiating antihormone therapy at the Dept. of Oncology, Aarhus University Hospital (AUH) will be included in the study over 6 months from autumn 2024. Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up. The two metabolic screenings each consists of biometric measurements and a blood sample.",[66,67,68],"Early Breast Cancer","Metabolic Health","Estrogen Receptor Positive Breast Cancer",[70,71,72],"Early breast cancer","Metabolic health","Endocrine therapy","NOT_YET_RECRUITING","2024-10-01",{"date":76,"type":77},"2024-10-02","ACTUAL",{"date":79,"type":61},"2024-11-01",{"date":81,"type":61},"2025-07-31",{"name":5,"class":6},1]