MedTrace Logo

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

NCT04469296 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-16

No results posted yet for this 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

Conditions

Interventions

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Veronique D'HONDT, MD · ICM Val d'Aurelle

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469296 on ClinicalTrials.gov