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

NCT04469296 | Recruiting

• 1 other identifier: PROICM 2019-05 MAC
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Cancer; Surgery

Keywords

dietary survey,

Outcome Measures

Primary Outcomes (1)

• study of the compliance of patients to the two proposed diets. The proportion of compliant patients to the proposed diet according to the dietary survey realized during 3 days

  A patient is considered compliant to the diet if the caloric intake is equal +/- 25% to the caloric intake of the proposed diet AND For the ketogenic diet : the carbohydrate intake is equal +/- 25% to the carbohydrate intake of the proposed diet; i.e. a carbohydrate intake between 7.5 and 12.5% of the total energy intake For the protein restricted diet, the protein intake is equal +/- 25% to the protein intake proposed for this diet; i.e. a reduction between 15 and 25% compared to the previous protein intake

  during 3 days before the primary surgery

Secondary Outcomes (8)

• study of the molecular consequences of diet modifications on cancer cells and their microenvironment

  At the inclusion visit and the day of surgery

• study of the molecular consequences of diet modifications on cancer cells and their microenvironment

  At the inclusion visit and the day of surgery

• evaluation of patient's tolerability to those diet modifications, in terms of weight status

  From the inclusion visit until the Day 45 post surgery

• evaluation of patient's tolerability to those diet modifications, in terms of adverse events

  From the inclusion visit until the Day 45 post surgery

• assessment of the acceptance of study participation and reasons for refusal

  During 45 days before the surgery

Study Arms (3)

control arm

NO INTERVENTION

In the control arm, patients will continue their usual diet without further recommendation.

specific diet arm "Ketogenic arm"

EXPERIMENTAL

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.

Dietary Supplement: iso-caloric ketogenic diet

specofoc diet arm "protein restricted diet"

EXPERIMENTAL

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.

Dietary Supplement: protein restricted diet

Interventions

iso-caloric ketogenic diet DIETARY_SUPPLEMENT

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

specific diet arm "Ketogenic arm"

protein restricted diet DIETARY_SUPPLEMENT

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.

specofoc diet arm "protein restricted diet"

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

RECRUITING

Related Publications (10)

• Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.

  PMID: 22237782 RESULT

• Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26.

  PMID: 22539238 RESULT

• Cairns RA, Mak TW. Fire and water: Tumor cell adaptation to metabolic conditions. Exp Cell Res. 2017 Jul 15;356(2):204-208. doi: 10.1016/j.yexcr.2017.04.029. Epub 2017 Apr 27.

  PMID: 28457987 RESULT

• Vander Heiden MG, DeBerardinis RJ. Understanding the Intersections between Metabolism and Cancer Biology. Cell. 2017 Feb 9;168(4):657-669. doi: 10.1016/j.cell.2016.12.039.

  PMID: 28187287 RESULT

• Chen Y, Ling L, Su G, Han M, Fan X, Xun P, Xu G. Effect of Intermittent versus Chronic Calorie Restriction on Tumor Incidence: A Systematic Review and Meta-Analysis of Animal Studies. Sci Rep. 2016 Sep 22;6:33739. doi: 10.1038/srep33739.

  PMID: 27653140 RESULT

• Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.

  PMID: 25815989 RESULT

• Lv M, Zhu X, Wang H, Wang F, Guan W. Roles of caloric restriction, ketogenic diet and intermittent fasting during initiation, progression and metastasis of cancer in animal models: a systematic review and meta-analysis. PLoS One. 2014 Dec 11;9(12):e115147. doi: 10.1371/journal.pone.0115147. eCollection 2014.

  PMID: 25502434 RESULT

• O'Flanagan CH, Smith LA, McDonell SB, Hursting SD. When less may be more: calorie restriction and response to cancer therapy. BMC Med. 2017 May 24;15(1):106. doi: 10.1186/s12916-017-0873-x.

  PMID: 28539118 RESULT

• Weber DD, Aminzadeh-Gohari S, Tulipan J, Catalano L, Feichtinger RG, Kofler B. Ketogenic diet in the treatment of cancer - Where do we stand? Mol Metab. 2020 Mar;33:102-121. doi: 10.1016/j.molmet.2019.06.026. Epub 2019 Jul 27.

  PMID: 31399389 RESULT

• A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7. No abstract available.

  PMID: 20318124 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Veronique D'HONDT, MD

  ICM Val d'Aurelle

  STUDY CHAIR

Central Study Contacts

Aurore Moussion

CONTACT

04 67 61 31 02; DRCI-icm105@icm.unicancer.fr

Emmanuelle Texier

CONTACT

04 67 61 31 02; DRCI-icm105@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: May 18, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Access to study data upon written detailed request sent to the institute of Montpellier Cancer (ICM), following publication and until 5 years after publication of summary data.
• Access Criteria: The data shared will be limited to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

Locations

FR (1)