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

NCT06610565 | Recruiting DMC

• 1 other identifier: IEO 1570
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

fasting-mimicking diet

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intervention arm

EXPERIMENTAL

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

control arm

EXPERIMENTAL

control arm where they will receive only nutritional counseling

Dietary Supplement: FASTING-MIMICKING DIET PROGRAM

Interventions

FASTING-MIMICKING DIET PROGRAM 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; intervention arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

IEO

Milan, Italy, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giuseppe Curigliano

  IEO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Curigliano

CONTACT

+39 02 57489788; giuseppe.curigliano@ieo.it

Ida Minchella

CONTACT

+39 02 94379908; ida.minchella@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

IT (1)