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

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About this study

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

Condition
Breast Cancer, Surgery
Tested
iso-caloric ketogenic diet, protein restricted diet
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

Who can join

Age
18 to 80 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Eligible sex: Female
  • Study condition: Breast Cancer, Surgery
  • 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 14

  • 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.

Where

1 site, 1 recruiting

Icm Val D'Aurelle

Montpellier, Herault, France

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.