Diet modification for patients with early luminal breast cancer before surgery

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

This study is testing whether changing to a ketogenic or protein-restricted diet for 9 days can help women with early luminal breast cancer before their surgery and how their feelings might affect their ability to stick to the diet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (other)
• Locations: 1 site (Montpellier, Herault)
• Trial ID: NCT04469296 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 80 with non-metastatic, ER and/or PR positive, HER2 negative invasive breast carcinoma, who are candidates for primary surgery.

Not a fit: Patients with metastatic breast cancer or those who have already received treatment for their current cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary interventions that may enhance treatment outcomes for breast cancer patients.

How similar studies have performed: While dietary modifications in cancer treatment are being explored, this specific approach is novel and lacks extensive prior testing.

Eligibility criteria

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 this trial is running

Montpellier, Herault

• Icm Val D'Aurelle — Montpellier, Herault, France (RECRUITING)

Study contacts

• Study coordinator: Aurore Moussion

Conditions: Breast Cancer, Surgery, dietary survey,