Ireland
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Recruiting Not applicable

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

NCT04469296 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-05-18
Last updated
2026-01-16

Condition(s) studied

Breast CancerSurgery

Investigational drug(s) / intervention(s)

iso-caloric ketogenic dietprotein restricted diet

iso-caloric ketogenic diet: Each patient will be offered a daily diet plan that includes the different groups of low glycemic index foods to bring to each meal and snack, with the notion of quantity. Carbohydrate-free foods can be consumed ad libitum. Dietary advice will be given to increase the consumption of lipid foods (vegetable oils, butter, cheeses, fatty fish, etc.) so that 65% of the total energy intake is provided by lipids. In addition, a list of unauthorized sugars and sweeteners substitutes will be proposed as well as a low glycemic index food composition table centered on carbohydrates for better control of food choice

protein restricted diet: A diet reducing by 20% the amount of protein compared to the usual intake of the patient will be proposed. This new ration will be carried out by calculating the proportion of total energy intake provided by the amount of protein reduced by 20% compared to the usual intake, and by modifying lipid and carbohydrate intakes to obtain an isocaloric ration.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • study of the compliance of patients to the two proposed diets. The proportion of compliant patients to the proposed diet according to the dietary survey realized during 3 days — during 3 days before the primary surgery
    A patient is considered compliant to the diet if the caloric intake is equal +/- 25% to the caloric intake of the proposed diet AND For the ketogenic diet : the carbohydrate intake is equal +/- 25% to the carbohydrate intake of the proposed diet; i.e. a carbohydrate intake between 7.5 and 12.5% of the total energy intake For the protein restricted diet, the protein intake is equal +/- 25% to the protein intake proposed for this diet; i.e. a reduction between 15 and 25% compared to the previous protein intake

Trial sites (1)

FacilityCityRegionStatus
Icm Val D'Aurelle Montpellier Herault Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04469296 on ClinicalTrials.gov ↗ ← All trials in France