Fasting-mimicking diet to lower cholesterol and reduce side effects from aromatase inhibitors in breast cancer patients.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with early-stage, ER-positive breast cancer who have high total cholesterol and have been on aromatase inhibitors for at least six months will follow short cycles of a fasting-mimicking diet program. Total cholesterol is the primary endpoint, measured before and after diet cycles, with dietary adherence monitored by telephone recalls and clinic visits. The protocol requires adequate organ function, WHO performance status 0-2, and willingness to provide biomaterials and follow-up data. The intervention is delivered at the European Institute of Oncology in Milan, Italy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ieo
  Milan, Italy, Italy Recruiting

Study contacts

• Principal investigator: Giuseppe Curigliano — Ieo
• Study coordinator: Giuseppe Curigliano
• Email: giuseppe.curigliano@ieo.it
• Phone: +39 02 57489788

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.