Could a monthly 5-Day diet ease breast cancer treatment side effects?
NCT ID NCT06610565
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a special low-calorie diet that mimics fasting, taken for 5 days each month for 6 months, can lower cholesterol and reduce side effects from aromatase inhibitors in post-menopausal breast cancer patients. Sixty women on hormone therapy will be randomly assigned to either the diet plus nutritional counseling or counseling alone. The main goal is to see if the diet is feasible and safe, and whether it helps lower total cholesterol.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fasting-mimicking diet
- What this could lead to
- If it works, this could offer a simple dietary approach to reduce cholesterol and side effects from hormone therapy in breast cancer survivors.
- What could go wrong
- This is a small early feasibility study with only 60 participants, so results may not apply widely. The diet is short-term and may be hard to follow for some.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IEO
RECRUITINGMilan, Italy, 20141, Italy
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