Actively Recruiting
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
Led by European Institute of Oncology · Updated on 2026-02-11
60
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- WHO performance status score 0-2
- Early stage breast cancer, ER positive, receiving 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 will not qualify if you...
- Underweight (BMI < 18.5 kg/m2)
- Current or past eating disorders identified with the SCOFF Questionnaire
- Moderate risk of malnutrition as identified by Malnutrition Universal Screening Tool (MUST)
- 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 or other drugs that interfere with lipid absorption
- Known 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
- Diabetes
- History of allergic reactions likely to be exacerbated by any component of the investigational product
- Other severe medical problems unrelated to the malignancy that limit compliance or increase risk
- Previous or concurrent malignancies at other sites except effectively treated malignancy considered cured
- Psychiatric or addictive disorders that may compromise informed consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IEO
Milan, Italy, Italy, 20141
Actively Recruiting
Research Team
G
Giuseppe Curigliano
CONTACT
I
Ida Minchella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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