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

What this trial studies

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 in scope

• Breast Cancer

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…

Who can join

Women only · Ages 18 Years and up

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

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-09-01
• Primary completion: 2027-04-01
• Last update posted: 2026-02-11
• First posted: 2024-09-24

Sponsor & contact

Lead sponsor: European Institute of Oncology (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Fasting-mimicking diet (from baseline to the end of treatment at 12 month)
  Determination of number of cycles of short term FMD exposure to a fasting-mimicking diet in reducing total cholesterol levels

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