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

Breast Cancer Clinical Trial

Official title: Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

• NCT number: NCT04469296
• Study type: Interventional
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Aurore Moussion
• Phone: 04 67 61 31 02
• Email: DRCI-icm105@icm.unicancer.fr
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2021
• Completion date: March 2025