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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: FASTING-MIMICKING DIET PROGRAM

Detailed Description

the short term FMD exposure to a fasting-mimicking diet reduce total cholesterol levels

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Curigliano; Phone Number: +39 02 57489788; Email: giuseppe.curigliano@ieo.it
• Study Contact Backup: Name: Ida Minchella; Phone Number: +39 02 94379908; Email: ida.minchella@ieo.it

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy, 20141
      • Recruiting
      • IEO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• 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
• Use of statins or supplements similar to statins (e.g red rice) or other drugs that interfere with lipid absorption (e.g ezetimibe)
• 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
• History of allergic reactions likely to be exacerbated by any component of the investigational product used in the study
• 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
• Previous or concomitant malignancies at other sites, except effectively treated malignancy that is considered by the Investigator to have been cured
• Psychiatric or addictive disorders that may compromise the ability to give informed consent or to comply with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; intervention arm where will receive nutritional counseling and the study diet for 5 days each month for 6 months	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.
Experimental: control arm; control arm where they will receive only nutritional counseling	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Giuseppe Curigliano, IEO

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: fasting-mimicking diet
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IEO 1570

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No