Diet modification for patients with early luminal breast cancer before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the feasibility of dietary modifications, specifically a ketogenic or protein-restricted diet, for women with early luminal breast cancer prior to primary surgery. The study will assess patient compliance with the diet over a period of 9 days, while also analyzing metabolic changes and potential antitumor effects. Additionally, the impact of patients' beliefs, anxiety, and depression on their ability to adhere to the diet will be examined. The goal is to gather data that could inform larger prospective trials in the future.

Why it matters

Who can join: the full rules

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.

Where it's running

• Icm Val D'Aurelle
  Montpellier, Herault, France Recruiting

Study contacts

• Study coordinator: Aurore Moussion
• Email: DRCI-icm105@icm.unicancer.fr
• Phone: 04 67 61 31 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.