Fasting-mimicking diet to lower cholesterol and reduce side effects from aromatase inhibitors in breast cancer patients.
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
This trial tests whether short cycles of a fasting-mimicking diet can lower total cholesterol in adults with early ER-positive breast cancer who are taking aromatase inhibitors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06610565 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with early-stage ER-positive breast cancer on adjuvant aromatase inhibitors for at least six months who have hypercholesterolemia (>200 mg/dL), adequate organ function, WHO performance status 0-2, and can attend follow-up and provide dietary recalls are ideal candidates.
Not a fit: Patients without elevated cholesterol, those not on aromatase inhibitors, people with metastatic disease, or those unable to follow dietary protocols or lacking adequate organ function are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the diet could lower patients' total cholesterol and potentially reduce cardiovascular risk associated with aromatase inhibitor therapy.
How similar studies have performed: Previous fasting-mimicking diet studies have shown improvements in metabolic markers and tolerability in cancer populations, but applying FMD specifically to lower cholesterol during aromatase inhibitor treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.