Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer

Inclusion Criteria: * Age ≥ 18 years * WHO performance status score 0-2 * Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor * Hypercholesterolemic (total cholesterol \>200mg/dL) * Ongoing treatment with aromatase inhibitors (at least six months of drug exposure) * Adequate renal, hepatic, and hematopoietic function * Written and informed consent for biomaterial submission and participation in the clinical trial * Compliance with treatment and follow up protocol * No other investigational agent may be administered concurrently to patients enrolled in this trial * Patients with skeletal pain are eligible if bone scan and/or RX examination fails to disclose metastatic disease * The interval between the onset of systemic adjuvant therapy with AIs and the randomization should be at least 6 months * Patient is accessible geographically for follow-up and must be able to provide dietary data via telephone recalls * Must be medically able to accept either dietary supplementation group prior to randomization. Exclusion Criteria: * Underweight (BMI \< 18.5 kg/m2) * Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) \[19\] * 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;…