Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery (MACS)
Breast Cancer, Surgery
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring dietary survey,
Eligibility Criteria
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.
Sites / Locations
- Icm Val D'AurelleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
control arm
specific diet arm "Ketogenic arm"
specofoc diet arm "protein restricted diet"
In the control arm, patients will continue their usual diet without further recommendation.
In the specific diet arms, the study diet will be calculated with a dietician, for the ketogenic diet, an iso-caloric ketogenic will be proposed and explained to the patient Each diet will be respected by the patient during 9 days +/- 1 day.
In the specific diet arms, the study diet will be calculated with a dietician, for the protein restricted diet, a 20% protein restriction as compared to the usual diet will be calculated and the diet will be explained to the patient. Each diet will be respected by the patient during 9 days +/- 1 day.