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

European Institute of Oncology

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Dietary Supplement: FASTING-MIMICKING DIET PROGRAM

Study type

Interventional

Funder types

Other

Identifiers

NCT06610565

IEO 1570

Details and patient eligibility

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.

Full description

the short term FMD exposure to a fasting-mimicking diet reduce total cholesterol levels

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 &gt;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 &lt; 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.