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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка 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
• Пищевая добавка 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.

Первичные конечные точки

• 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 [Срок оценки: during 3 days before the primary surgery]

Вторичные конечные точки (8)

• study of the molecular consequences of diet modifications on cancer cells and their microenvironment [Срок оценки: At the inclusion visit and the day of surgery]
• study of the molecular consequences of diet modifications on cancer cells and their microenvironment [Срок оценки: At the inclusion visit and the day of surgery]
• evaluation of patient's tolerability to those diet modifications, in terms of weight status [Срок оценки: From the inclusion visit until the Day 45 post surgery]
• evaluation of patient's tolerability to those diet modifications, in terms of adverse events [Срок оценки: From the inclusion visit until the Day 45 post surgery]
• assessment of the acceptance of study participation and reasons for refusal [Срок оценки: During 45 days before the surgery]
• determination of the impact of diet modification on patient's quality of life [Срок оценки: From the inclusion visit until the Day 45 post surgery]
• evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet. [Срок оценки: From the inclusion visit until the Day 45 post surgery]
• evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet [Срок оценки: From the inclusion visit until the Day 45 post surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Icm Val D'Aurelle — Montpellier

Публикации

• 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. 20 PMID 22237782
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT04469296 · PROICM 2019-05 MAC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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