Breast CancerNCT06610565
Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
A study testing FASTING-MIMICKING DIET PROGRAM in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FASTING-MIMICKING DIET PROGRAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
the short term FMD exposure to a fasting-mimicking diet reduce total cholesterol levels
- Conditions
- Breast Cancer
- Being tested
- FASTING-MIMICKING DIET PROGRAM
- Keywords
- fasting-mimicking diet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTING-MIMICKING DIET PROGRAMDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | intervention arm where will receive nutritional counseling and the study diet for 5 days each month for 6 months Receives: Dietary Supplement: FASTING-MIMICKING DIET PROGRAM |
| control arm | Experimental | control arm where they will receive only nutritional counseling Receives: Dietary Supplement: FASTING-MIMICKING DIET PROGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting-mimicking diet
Determination of number of cycles of short term FMD exposure to a fasting-mimicking diet in reducing total cholesterol levels
Measured: from baseline to the end of treatment at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Curigliano, Principal investigator, IEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610565
- Sponsor's protocol ID
- IEO 1570
- Status last verified
- Feb 2026
- First submitted
- 20 Sep 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06610565
- Acronym / sponsor ID
- IEO 1570
- Conditions
- Breast Cancer
- Keywords
- fasting-mimicking diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Dietary Supplement: FASTING-MIMICKING DIET PROGRAMintervention arm where will receive nutritional counseling and the study diet for 5 days each month for 6 months |
| control arm | Experimental | Dietary Supplement: FASTING-MIMICKING DIET PROGRAMcontrol arm where they will receive only nutritional counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTING-MIMICKING DIET PROGRAMNutritional 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. | Dietary supplement | control arm, intervention arm |
Primary outcome
Fasting-mimicking diet
Time frame: from baseline to the end of treatment at 12 month
Determination of number of cycles of short term FMD exposure to a fasting-mimicking diet in reducing total cholesterol levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Curigliano principal investigator
IEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASTING-MIMICKING DIET PROGRAM in people with Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Curigliano (+39 02 57489788, giuseppe.curigliano@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting-mimicking diet (time frame: from baseline to the end of treatment at 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.