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

NCT ID: NCT06610565

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-04-01

Brief Summary

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.

Detailed Description

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

intervention arm

intervention arm where will receive nutritional counseling and the study diet for 5 days each month for 6 months

Group Type: EXPERIMENTAL

FASTING-MIMICKING DIET PROGRAM

Intervention Type: DIETARY_SUPPLEMENT

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.

control arm

control arm where they will receive only nutritional counseling

Group Type: EXPERIMENTAL

FASTING-MIMICKING DIET PROGRAM

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Curigliano

Role: PRINCIPAL_INVESTIGATOR

IEO

Locations

IEO

Milan, , Italy

Countries

Italy

Other Identifiers

IEO 1570

Identifier Type: -

Identifier Source: org_study_id