Status:
RECRUITING
Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Surgery
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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 su...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04469296
Start Date
May 18 2021
End Date
April 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Icm Val D'Aurelle
Montpellier, Herault, France, 34298