Many patients are modifying their diet after the diagnosis of cancer. There is a supposedly
benefit, among the general public, of starving cancer cells with several diet deprivations.
Due to the lack of coherent scientific data, no evidence base recommendations can be made
regarding the optimal diet during cancer and its effect on cancer growth.
The objective of this trial is to analyze the feasibility for patients with early luminal
breast cancer to be compliant with a diet modification - ketogenic or proteins restricted
diet - during 9 +/- 1 days, before breast cancer surgery.
The primary objective of the trial is to evaluate the compliance to the proposed diet.
The study will be conducted in patients with luminal early breast cancer, candidate to
primary surgery, in order to study an homogeneous population of patients, with good
performance status and without nutritional deprivation.
Metabolic changes on the main metabolic pathways and the potential antitumor effects related
to these metabolic changes following the diet will be analyzed as secondary objectives of the
study. We hope to find biological hypotheses to further test in a next larger prospective
The impact of the patient's beliefs, anxiety and/or depression on the compliance will be
analyzed as well.
- 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) 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
- ECG with a QTc interval ≤ 450 msec
- Patient able to understand, participate and give a written consent for participation
to the study
- 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
- 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
- Individuals under the protection of a conservator
- Unaffiliated patient to Social Protection System.