RecruitingNot ApplicableNCT06610565

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

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

Sponsor

European Institute of Oncology

Enrollment

60 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria13

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 Criteria10

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.

Interventions

DIETARY_SUPPLEMENTFASTING-MIMICKING DIET PROGRAM

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 one, where they will receive only nutritional counseling.