[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563007":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":52,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention arm","EXPERIMENTAL","intervention arm where will receive nutritional counseling and the study diet for 5 days each month for 6 months",[13],"Dietary Supplement: FASTING-MIMICKING DIET PROGRAM",{"label":15,"type":10,"description":16,"interventionNames":17},"control arm","control arm where they will receive only nutritional counseling",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","FASTING-MIMICKING DIET PROGRAM","Nutritional intervention via fasting-mimicking diet. Patients receiving adjuvant therapy with aromatase inhibitors will be randomized 1:1 into two arms: one intervention, where will receive nutritional counseling and the study diet for 5 days each month for 6 months,and a control one, where they will receive only nutritional counseling.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Giuseppe Curigliano","IEO","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+39 02 57489788","giuseppe.curigliano@ieo.it",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Ida Minchella","+39 02 94379908","ida.minchella@ieo.it",[40],{"facility":28,"status":41,"city":42,"state":43,"zip":44,"country":43,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"RECRUITING","Milan","Italy","20141","IT",{"type":47,"coordinates":48},"Point",[49,50],9.18951,45.46427,{"lat":50,"lon":49},{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100563007","fasting-mimicking-diet-intervention-on-side-effects-of-aromatase-inhibitors-treatment-in-patients-with-breast-cancer-100563007",false,"NCT06610565","Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer","Fasting-mimicking Diet: A Randomized Trial on Feasibility, Safety and Effects of Multicycle Dietary Intervention on Side Effects of Aromatase Inhibitors Treatment in Post-menopausal Patients With Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* WHO performance status score 0-2\n* Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor\n* Hypercholesterolemic (total cholesterol \\>200mg\u002FdL)\n* Ongoing treatment with aromatase inhibitors (at least six months of drug exposure)\n* Adequate renal, hepatic, and hematopoietic function\n* Written and informed consent for biomaterial submission and participation in the clinical trial\n* Compliance with treatment and follow up protocol\n* No other investigational agent may be administered concurrently to patients enrolled in this trial\n* Patients with skeletal pain are eligible if bone scan and\u002For RX examination fails to disclose metastatic disease\n* The interval between the onset of systemic adjuvant therapy with AIs and the randomization should be at least 6 months\n* Patient is accessible geographically for follow-up and must be able to provide dietary data via telephone recalls\n* Must be medically able to accept either dietary supplementation group prior to randomization.\n\nExclusion Criteria:\n\n* Underweight (BMI \\< 18.5 kg\u002Fm2)\n* Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) \\[19\\]\n* Malnutrition Universal Screening Tool (MUST). It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥1 identify a patient at moderate risk of malnutrition;\n* Treatment with any investigational or non-registered drug other than the study product(s) within 30 days preceding the first dose of study product, or planned use during the study period\n* Use of statins or supplements similar to statins (e.g red rice) or other drugs that interfere with lipid absorption (e.g ezetimibe)\n* Known to have difficult-to-control hypertension, coronary artery disease, arrhythmia requiring treatment, clinically significant valvular disease, cardiomegaly on chest X-ray, ventricular hypertrophy on ECG, previous myocardial infarction, or congestive heart failure Patients with diabetes are not eligible for the study\n* History of allergic reactions likely to be exacerbated by any component of the investigational product used in the study\n* Other concurrent, severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk\n* Previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the Investigator to have been cured\n* Psychiatric or addictive disorders that may compromise the ability to give informed consent or to comply with study procedures.","FEMALE","18 Years",{"count":64,"type":65},60,"ESTIMATED","INTERVENTIONAL",[68],"NA","The primary endpoint of this study is to determine whether cycles of short term FMD exposure to a fasting-mimicking diet is effective in reducing total cholesterol levels.",[71],"Breast Cancer",[73],"fasting-mimicking diet","2026-02-09",{"date":76,"type":77},"2026-02-11","ACTUAL",{"date":79,"type":77},"2024-09-01",{"date":81,"type":65},"2027-04-01",{"name":5,"class":6},1]