Clinical trial NCT06610565: Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: fasting-mimicking diet
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization 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.
Primary purpose: OTHER

Brief 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.

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

Eligibility 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 \&amp;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 \&amp;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.

Primary outcomes:
measure: Fasting-mimicking diet
timeFrame: from baseline to the end of treatment at 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO
Study officials:
affiliation: IEO
name: Giuseppe Curigliano
role: PRINCIPAL_INVESTIGATOR
References: