Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
Institut du Cancer de Montpellier - Val d'Aurelle
75 participants
May 18, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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 Criteria14
- 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.
Interventions
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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04469296