Status:
ACTIVE_NOT_RECRUITING
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06610565
Start Date
September 1 2024
End Date
April 1 2027
Last Update
September 24 2024
Active Locations (1)
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1
IEO
Milan, Italy, 20141