[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563007":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":32,"overallOfficials":38,"centralContacts":43,"locations":52,"responsibleParty":65,"collaborators":13,"id":67,"slug":13,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":13,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":13,"enrollmentInfo":75,"targetDuration":13,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":54,"whyStopped":13,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"European Institute of Oncology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Fasting-mimicking diet","Determination of number of cycles of short term FMD exposure to a fasting-mimicking diet in reducing total cholesterol levels","from baseline to the end of treatment at 12 month",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":6,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","1:1 randomization 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.",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","the short term FMD exposure to a fasting-mimicking diet reduce total cholesterol levels",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"intervention arm","EXPERIMENTAL","intervention arm where will receive nutritional counseling and the study diet for 5 days each month for 6 months",[27],"Dietary Supplement: FASTING-MIMICKING DIET PROGRAM",{"label":29,"type":24,"description":30,"interventionNames":31},"control arm","control arm where they will receive only nutritional counseling",[27],[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":13},"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.",[29,23],[39],{"name":40,"affiliation":41,"role":42},"Giuseppe Curigliano","IEO","PRINCIPAL_INVESTIGATOR",[44,48],{"name":40,"role":45,"phone":46,"phoneExt":13,"email":47},"CONTACT","+39 02 57489788","giuseppe.curigliano@ieo.it",{"name":49,"role":45,"phone":50,"phoneExt":13,"email":51},"Ida Minchella","+39 02 94379908","ida.minchella@ieo.it",[53],{"facility":41,"status":54,"city":55,"state":56,"zip":57,"country":56,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":13},"RECRUITING","Milan","Italy","20141","IT",{"type":60,"coordinates":61},"Point",[62,63],9.18951,45.46427,{"lat":63,"lon":62},{"type":66,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83],"Breast Cancer",[85],"fasting-mimicking diet","2026-02-09",{"date":88,"type":89},"2026-02-11","ACTUAL",{"date":91,"type":89},"2024-09-01",{"date":93,"type":77},"2027-04-01",{"name":5,"class":6},1]