Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT04469296

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

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-01-16

75

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18 to 80 years old
  • Invasive breast carcinoma, non-metastatic, stage I to III, ER and/or PR positive, HER2 negative (luminal)
  • No prior treatment for current breast cancer
  • Candidate for primary surgery
  • BMI between 18.5 and 30 for women up to 70 years old; BMI between 21 and 30 for women 70 to 80 years old
  • For women 70 years or older, Oncodage G8 score over 14 or oncogeriatrician approval
  • No metabolism-altering addictions (alcohol ≤ 2 glasses/day or ≤ 10 glasses/week; tobacco occasional or stopped ≥ 6 months)
  • Performance status 0-1
  • Fasting blood tests within normal specified ranges
  • ECG with QTc interval ≤ 450 msec
  • Ability to understand and provide written informed consent
Not Eligible

You will not qualify if you...

  • Metabolic disease or other condition impairing metabolism analysis
  • High-level athlete
  • Unintentional weight loss ≥ 5% in last month or ≥ 10% in last 6 months
  • Use of unjustified dietary supplements in last month
  • Restricted or unbalanced diet (e.g., vegan, hypocaloric, hyper or hypo protein) in last month
  • Fasting practice in last 3 months
  • Corticoid use that cannot be stopped or not stopped for 2 weeks
  • Diabetes mellitus (with or without insulin)
  • Hypercholesterolemia requiring treatment
  • Invasive lobular carcinoma
  • Pregnant or breastfeeding
  • Participation in another investigational treatment study in last 30 days
  • Under legal protection conservator
  • Not affiliated with Social Protection System

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Icm Val D'Aurelle

Montpellier, Herault, France, 34298

Actively Recruiting

Loading map...

Research Team

A

Aurore Moussion

CONTACT

E

Emmanuelle Texier

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here