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

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Surgery

In brief

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

Key facts

Study ID

NCT04469296

Run by

Institut du Cancer de Montpellier - Val d'Aurelle

People needed

75

Starts

2021-05-18

Expected to finish

2026-12-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Icm Val D'Aurelle — Montpellier, Herault, France (enrolling)

Full record on ClinicalTrials.gov

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