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Trial Title:
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
NCT ID:
NCT06610565
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
fasting-mimicking diet
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
FASTING-MIMICKING DIET PROGRAM
Description:
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.
Arm group label:
control arm
Arm group label:
intervention arm
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
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
only female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IEO
Address:
City:
Milan
Zip:
20141
Country:
Italy
Start date:
September 1, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610565
