Recruiting NCT06610565
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FASTING-MIMICKING DIET PROGRAM.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Dietary supplement FASTING-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.
Primary outcome measures
- Fasting-mimicking diet [Time frame: from baseline to the end of treatment at 12 month]
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 \>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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- IEO — Milan
Identifiers
NCT: NCT06610565 · IEO 1570