Can a Pre-Surgery diet alter breast cancer cells? new study investigates
NCT ID NCT04469296
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 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGMontpellier, Herault, 34298, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?