Clinical trial NCT04469296: Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
Official title: Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Surgery
Keywords: dietary survey,
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

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.

Primary outcomes:
measure: 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
timeFrame: during 3 days before the primary surgery
Secondary outcomes:
measure: study of the molecular consequences of diet modifications on cancer cells and their microenvironment
timeFrame: At the inclusion visit and the day of surgery
measure: study of the molecular consequences of diet modifications on cancer cells and their microenvironment
timeFrame: At the inclusion visit and the day of surgery
measure: evaluation of patient's tolerability to those diet modifications, in terms of weight status
timeFrame: From the inclusion visit until the Day 45 post surgery
measure: evaluation of patient's tolerability to those diet modifications, in terms of adverse events
timeFrame: From the inclusion visit until the Day 45 post surgery
measure: assessment of the acceptance of study participation and reasons for refusal
timeFrame: During 45 days before the surgery
measure: determination of the impact of diet modification on patient's quality of life
timeFrame: From the inclusion visit until the Day 45 post surgery
measure: evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.
timeFrame: From the inclusion visit until the Day 45 post surgery
measure: evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet
timeFrame: From the inclusion visit until the Day 45 post surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Icm Val D'Aurelle
state: Herault
Study officials:
affiliation: ICM Val d'Aurelle
name: Veronique D'HONDT, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7. No abstract available.