NCT04469296

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Breast Cancer
• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-07-14
• Last updated: 2026-01-16

Locations

1 site across 1 country: France