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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Icm Val D'Aurelle
RECRUITING
Montpellier
Contact Information
Primary
Aurore Moussion
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Backup
Emmanuelle Texier
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Time Frame
Start Date: 2021-05-18
Estimated Completion Date: 2026-04
Participants
Target number of participants: 75
Treatments
No_intervention: control arm
In the control arm, patients will continue their usual diet without further recommendation.
Experimental: specific diet arm Ketogenic arm
In the specific diet arms, the study diet will be calculated with a dietician, for the ketogenic diet, an iso-caloric ketogenic will be proposed and explained to the patient Each diet will be respected by the patient during 9 days +/- 1 day.
Experimental: specofoc diet arm protein restricted diet
In the specific diet arms, the study diet will be calculated with a dietician, for the protein restricted diet, a 20% protein restriction as compared to the usual diet will be calculated and the diet will be explained to the patient.~Each diet will be respected by the patient during 9 days +/- 1 day.
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov