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Can a Pre-Surgery diet alter breast cancer cells? new study investigates

NCT ID NCT04469296

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether women with early-stage luminal breast cancer can follow a special diet (ketogenic or protein-restricted) for about 9 days before their surgery. The main goal is to see if patients can stick to the diet. Researchers will also look at how the diet affects cancer cells and the immune system using blood and tumor samples. It is a small pilot study with 75 participants, so it is mainly about gathering information for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iso-caloric ketogenic diet
What this could lead to
If successful, this study could show that short-term diet changes before surgery are feasible and may influence tumor biology, pointing toward future dietary interventions in breast cancer care.
What could go wrong
This is a very small, early pilot study (75 participants) focused on feasibility, not on curing cancer. It does not test whether the diet improves outcomes, and results may not apply to all patients.

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

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

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women 18 to 80 years old * Invasive breast carcinoma, non-metastatic, stage I to III, pathologically proven, ER and/or PR positive, HER2 negative (luminal) * No treatment yet for the current breast cancer * Candidate for primary surgery * Body mass index (BMI) between 18.5 and 30 for women up to 70 years old and between 21 and 30 for women between 70 and 80 years old. * For patient ≥ 70 years, score of the Oncodage G8 questionnaire \> 14 (if score ≤ 14, consultation with an oncogeriatrician required to validate the possibility of following a diet * No addiction (alcohol, tobacco, drug, electronic cigarette) that modifies the metabolism (alcohol : ≤ 2 glasses/d or ≤10 glasses/week ; tobacco : only occasional or stopped for ≥ 6 months) * Performance status 0-1 * Fasting blood test : Blood cell counts : Neutrophils \> 1000/µL, Platelets \> 100 000/µL, Hb \> 11g/dL Hepatic biology: GOT, GPT, GGT, Phosphatases alcalines \< 2x normal value Renal function : clearance \> 60 mL /min Lipid profile : Total cholesterol \< 1.5 x normal value, HDL\>0.35g/L, LDL \< 2.2 g/L (\<5.7 mml/L), Triglycerides \< 1.5 x normal value Fasting blood glucose \< 1.26 g/l Measurement of electrolytes: Potassium, Sodium, Calcium, Magnesium (according to normal laboratory values) * ECG with a QTc interval ≤ 450 msec * Patient able to understand, participate and give a written consent for participation to the study Exclusion Criteria: * Metabolic disease or other disease impairing the metabolism analysis * High level athlete * Unintentional weight loss ≥ 5% during the last month, or 10% during the last 6 months or compared to usual weight * Unjustified dietary supplement (not justified by a measured deficiency) during the last month * Restricted of unbalanced diet (vegan diet, restricted hypocaloric, hyper or hypo protein…) during the last month * Practice of fasting during the last 3 months * Corticoids that can't be stopped or not stopped for 2 weeks * Mellitus diabetes (with or without insulin) * Hypercholesterolemia requiring a treatment * Invasive lobular carcinoma * Pregnant or breast-feeding women * Participation to another study with an investigational treatment during the last 30 days * Individuals under the protection of a conservator * Unaffiliated patient to Social Protection System.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Icm Val D'Aurelle

    RECRUITING

    Montpellier, Herault, 34298, France

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