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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Enrolling

Conditions: Breast Cancer; Surgery

Treatments: Dietary Supplement: iso-caloric ketogenic diet; Dietary Supplement: protein restricted diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04469296

PROICM 2019-05 MAC

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

control arm

No Intervention group

Description:

In the control arm, patients will continue their usual diet without further recommendation.

specific diet arm "Ketogenic arm"

Experimental group

Description:

In the specific diet arms, the study diet will be calculated with a dietician, for the ketogenic diet, an iso-caloric ketogenic will be proposed and explained to the patient Each diet will be respected by the patient during 9 days +/- 1 day.

Treatment:

Dietary Supplement: iso-caloric ketogenic diet

specofoc diet arm "protein restricted diet"

Experimental group

Description:

In the specific diet arms, the study diet will be calculated with a dietician, for the protein restricted diet, a 20% protein restriction as compared to the usual diet will be calculated and the diet will be explained to the patient. Each diet will be respected by the patient during 9 days +/- 1 day.

Treatment:

Dietary Supplement: protein restricted diet