Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery

Summary

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. It's a Pilot study, monocentric, randomized

Eligibility

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.

Conditions3

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