Breast Cancer, Surgery
Conditions
Keywords
dietary survey,
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 surgery. It's a Pilot study, monocentric, randomized
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 of coherent scientific data, no evidence base recommendations can be made regarding the optimal diet during cancer and its effect on cancer growth. The objective of this trial is 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. The primary objective of the trial is to evaluate the compliance to the proposed diet. The study will be conducted in patients with luminal early breast cancer, candidate to primary surgery, in order to study an homogeneous population of patients, with good performance status and without nutritional deprivation. Metabolic changes on the main metabolic pathways and the potential antitumor effects related to these metabolic changes following the diet will be analyzed as secondary objectives of the study. We hope to find biological hypotheses to further test in a next larger prospective trial. The impact of the patient's beliefs, anxiety and/or depression on the compliance will be analyzed as well.
Interventions
DIETARY_SUPPLEMENTiso-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
DIETARY_SUPPLEMENTprotein 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.
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| study of the molecular consequences of diet modifications on cancer cells and their microenvironment | At the inclusion visit and the day of surgery | analyse markers of cell proliferation in cancer and immune cells with blood sample and tumor sample. Evaluation of markers involved in carbohydrate mitochondrial and lipid metabolism, and markers of the Pi3K-Akt-mTOR and the IGF-R pathways |
| evaluation of patient's tolerability to those diet modifications, in terms of weight status | From the inclusion visit until the Day 45 post surgery | Weight surveillance (in kilograms) |
| evaluation of patient's tolerability to those diet modifications, in terms of adverse events | From the inclusion visit until the Day 45 post surgery | monitoring of adverse events related to diet (with CTCAE (Common Terminology Criteria for Adverse Events) version 5.0) |
| assessment of the acceptance of study participation and reasons for refusal | During 45 days before the surgery | Rate of patients who agreed to participate in the study compared to the total number of patients to whom the study was proposed. Collection of reasons for refusing to participate to the study |
| determination of the impact of diet modification on patient's quality of life | From the inclusion visit until the Day 45 post surgery | Result of the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire |
| evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet. | From the inclusion visit until the Day 45 post surgery | Result of the questionnaire of Beliefs about diet and cancer OPINELE (Opinions concernant l'alimentation, la santé et le cancer) |
| evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet | From the inclusion visit until the Day 45 post surgery | Scores obtained on the HADS scale (Hospital Anxiety and Depression Scale) (if score or = 9, result is no significant, if sore is between 10 and 12, result is limit, if result is \> or = 13, result is significant |
Countries
France
Contacts
CONTACTAurore Moussion
CONTACTEmmanuelle Texier
STUDY_CHAIRVeronique D'HONDT, MD
ICM Val d'Aurelle
Outcome results
None listed