<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04469296</url>
  </required_header>
  <id_info>
    <org_study_id>PROICM 2019-05 MAC</org_study_id>
    <nct_id>NCT04469296</nct_id>
  </id_info>
  <brief_title>Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery</brief_title>
  <acronym>MACS</acronym>
  <official_title>Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      to analyze the feasibility for patients with early luminal breast cancer to be compliant with&#xD;
      a diet modification - ketogenic or proteins restricted diet - during 9 +/- 1 days, before&#xD;
      breast cancer surgery.&#xD;
&#xD;
      It's a Pilot study, monocentric, randomized&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients are modifying their diet after the diagnosis of cancer. There is a supposedly&#xD;
      benefit, among the general public, of starving cancer cells with several diet deprivations.&#xD;
&#xD;
      Due to the lack of coherent scientific data, no evidence base recommendations can be made&#xD;
      regarding the optimal diet during cancer and its effect on cancer growth.&#xD;
&#xD;
      The objective of this trial is to analyze the feasibility for patients with early luminal&#xD;
      breast cancer to be compliant with a diet modification - ketogenic or proteins restricted&#xD;
      diet - during 9 +/- 1 days, before breast cancer surgery.&#xD;
&#xD;
      The primary objective of the trial is to evaluate the compliance to the proposed diet.&#xD;
&#xD;
      The study will be conducted in patients with luminal early breast cancer, candidate to&#xD;
      primary surgery, in order to study an homogeneous population of patients, with good&#xD;
      performance status and without nutritional deprivation.&#xD;
&#xD;
      Metabolic changes on the main metabolic pathways and the potential antitumor effects related&#xD;
      to these metabolic changes following the diet will be analyzed as secondary objectives of the&#xD;
      study. We hope to find biological hypotheses to further test in a next larger prospective&#xD;
      trial.&#xD;
&#xD;
      The impact of the patient's beliefs, anxiety and/or depression on the compliance will be&#xD;
      analyzed as well.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 18, 2021</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <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</measure>
    <time_frame>during 3 days before the primary surgery</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>study of the molecular consequences of diet modifications on cancer cells and their microenvironment</measure>
    <time_frame>At the inclusion visit and the day of surgery</time_frame>
    <description>analyse markers of cell proliferation in cancer and immune cells with blood sample and tumor sample. Evaluation of markers involved in carbohydrate mitochondrial and lipid metabolism, and markers of the Pi3K-Akt-mTOR and the IGF-R pathways</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>study of the molecular consequences of diet modifications on cancer cells and their microenvironment</measure>
    <time_frame>At the inclusion visit and the day of surgery</time_frame>
    <description>determine the activity of the anti-tumoral immune surveillance with blood sample and tumor sample. Correlation between the cancer response and antitumoral immune with diet programm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of patient's tolerability to those diet modifications, in terms of weight status</measure>
    <time_frame>From the inclusion visit until the Day 45 post surgery</time_frame>
    <description>Weight surveillance (in kilograms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of patient's tolerability to those diet modifications, in terms of adverse events</measure>
    <time_frame>From the inclusion visit until the Day 45 post surgery</time_frame>
    <description>monitoring of adverse events related to diet (with CTCAE (Common Terminology Criteria for Adverse Events) version 5.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of the acceptance of study participation and reasons for refusal</measure>
    <time_frame>During 45 days before the surgery</time_frame>
    <description>Rate of patients who agreed to participate in the study compared to the total number of patients to whom the study was proposed. Collection of reasons for refusing to participate to the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>determination of the impact of diet modification on patient's quality of life</measure>
    <time_frame>From the inclusion visit until the Day 45 post surgery</time_frame>
    <description>Result of the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.</measure>
    <time_frame>From the inclusion visit until the Day 45 post surgery</time_frame>
    <description>Result of the questionnaire of Beliefs about diet and cancer OPINELE (Opinions concernant l'alimentation, la santé et le cancer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet</measure>
    <time_frame>From the inclusion visit until the Day 45 post surgery</time_frame>
    <description>Scores obtained on the HADS scale (Hospital Anxiety and Depression Scale) (if score or = 9, result is no significant, if sore is between 10 and 12, result is limit, if result is &gt; or = 13, result is significant</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control arm, patients will continue their usual diet without further recommendation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>specific diet arm &quot;Ketogenic arm&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>specofoc diet arm &quot;protein restricted diet&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Each diet will be respected by the patient during 9 days +/- 1 day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>iso-caloric ketogenic diet</intervention_name>
    <description>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</description>
    <arm_group_label>specific diet arm &quot;Ketogenic arm&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>protein restricted diet</intervention_name>
    <description>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.</description>
    <arm_group_label>specofoc diet arm &quot;protein restricted diet&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women 18 to 80 years old&#xD;
&#xD;
          -  Invasive breast carcinoma, non-metastatic, stage I to III, pathologically proven, ER&#xD;
             and/or PR positive, HER2 negative (luminal)&#xD;
&#xD;
          -  No treatment yet for the current breast cancer&#xD;
&#xD;
          -  Candidate for primary surgery&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 and 30 for women up to 70 years old and between 21&#xD;
             and 30 for women between 70 and 80 years old.&#xD;
&#xD;
          -  For patient ≥ 70 years, score of the Oncodage G8 questionnaire &gt; 14 (if score ≤ 14,&#xD;
             consultation with an oncogeriatrician required to validate the possibility of&#xD;
             following a diet&#xD;
&#xD;
          -  No addiction (alcohol, tobacco, drug, electronic cigarette) that modifies the&#xD;
             metabolism (alcohol : ≤ 2 glasses/d or ≤10 glasses/week ; tobacco : only occasional or&#xD;
             stopped for ≥ 6 months)&#xD;
&#xD;
          -  Performance status 0-1&#xD;
&#xD;
          -  Fasting blood test :&#xD;
&#xD;
        Blood cell counts : Neutrophils &gt; 1000/µL, Platelets &gt; 100 000/µL, Hb &gt; 11g/dL Hepatic&#xD;
        biology: GOT, GPT, GGT, Phosphatases alcalines &lt; 2x normal value Renal function : clearance&#xD;
        &gt; 60 mL /min Lipid profile : Total cholesterol &lt; 1.5 x normal value, HDL&gt;0.35g/L, LDL &lt; 2.2&#xD;
        g/L (&lt;5.7 mml/L), Triglycerides &lt; 1.5 x normal value Fasting blood glucose &lt; 1.26 g/l&#xD;
        Measurement of electrolytes: Potassium, Sodium, Calcium, Magnesium (according to normal&#xD;
        laboratory values)&#xD;
&#xD;
          -  ECG with a QTc interval ≤ 450 msec&#xD;
&#xD;
          -  Patient able to understand, participate and give a written consent for participation&#xD;
             to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic disease or other disease impairing the metabolism analysis&#xD;
&#xD;
          -  High level athlete&#xD;
&#xD;
          -  Unintentional weight loss ≥ 5% during the last month, or 10% during the last 6 months&#xD;
             or compared to usual weight&#xD;
&#xD;
          -  Unjustified dietary supplement (not justified by a measured deficiency) during the&#xD;
             last month&#xD;
&#xD;
          -  Restricted of unbalanced diet (vegan diet, restricted hypocaloric, hyper or hypo&#xD;
             protein…) during the last month&#xD;
&#xD;
          -  Practice of fasting during the last 3 months&#xD;
&#xD;
          -  Corticoids that can't be stopped or not stopped for 2 weeks&#xD;
&#xD;
          -  Mellitus diabetes (with or without insulin)&#xD;
&#xD;
          -  Hypercholesterolemia requiring a treatment&#xD;
&#xD;
          -  Invasive lobular carcinoma&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Participation to another study with an investigational treatment during the last 30&#xD;
             days&#xD;
&#xD;
          -  Individuals under the protection of a conservator&#xD;
&#xD;
          -  Unaffiliated patient to Social Protection System.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronique D'HONDT, MD</last_name>
    <role>Study Chair</role>
    <affiliation>ICM Val d'Aurelle</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurore Moussion</last_name>
    <phone>04 67 61 31 02</phone>
    <phone_ext>+33</phone_ext>
    <email>DRCI-icm105@icm.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Emmanuelle Texier</last_name>
    <phone>04 67 61 31 02</phone>
    <phone_ext>+33</phone_ext>
    <email>DRCI-icm105@icm.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Icm Val D'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Veronique D'HONDT, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <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>
    <PMID>22237782</PMID>
  </results_reference>
  <results_reference>
    <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. Erratum In: CA Cancer J Clin. 2013 May;63(3):215.</citation>
    <PMID>22539238</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>28457987</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>28187287</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>27653140</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>25815989</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>25502434</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>28539118</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>31399389</PMID>
  </results_reference>
  <results_reference>
    <citation>A D B. The Ketogenic Diet in Epilepsy. Can Med Assoc J. 1931 Jan;24(1):106-7. No abstract available.</citation>
    <PMID>20318124</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary survey,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469296
org study id: PROICM 2019-05 MAC
nct id: NCT04469296
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
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
time frame: during 3 days before the primary surgery
description: 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
measure: study of the molecular consequences of diet modifications on cancer cells and their microenvironment
time frame: At the inclusion visit and the day of surgery
description: analyse markers of cell proliferation in cancer and immune cells with blood sample and tumor sample. Evaluation of markers involved in carbohydrate mitochondrial and lipid metabolism, and markers of the Pi3K-Akt-mTOR and the IGF-R pathways
measure: study of the molecular consequences of diet modifications on cancer cells and their microenvironment
time frame: At the inclusion visit and the day of surgery
description: determine the activity of the anti-tumoral immune surveillance with blood sample and tumor sample. Correlation between the cancer response and antitumoral immune with diet programm
measure: evaluation of patient's tolerability to those diet modifications, in terms of weight status
time frame: From the inclusion visit until the Day 45 post surgery
description: Weight surveillance (in kilograms)
measure: evaluation of patient's tolerability to those diet modifications, in terms of adverse events
time frame: From the inclusion visit until the Day 45 post surgery
description: monitoring of adverse events related to diet (with CTCAE (Common Terminology Criteria for Adverse Events) version 5.0)
measure: assessment of the acceptance of study participation and reasons for refusal
time frame: During 45 days before the surgery
description: Rate of patients who agreed to participate in the study compared to the total number of patients to whom the study was proposed. Collection of reasons for refusing to participate to the study
measure: determination of the impact of diet modification on patient's quality of life
time frame: From the inclusion visit until the Day 45 post surgery
description: Result of the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire
measure: evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.
time frame: From the inclusion visit until the Day 45 post surgery
description: Result of the questionnaire of Beliefs about diet and cancer OPINELE (Opinions concernant l'alimentation, la santé et le cancer)
measure: evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet
time frame: From the inclusion visit until the Day 45 post surgery
description: Scores obtained on the HADS scale (Hospital Anxiety and Depression Scale) (if score or = 9, result is no significant, if sore is between 10 and 12, result is limit, if result is > or = 13, result is significant
arm group label: control arm
arm group type: No Intervention
description: In the control arm, patients will continue their usual diet without further recommendation.
arm group label: specific diet arm "Ketogenic arm"
arm group type: Experimental
description: 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.
arm group label: specofoc diet arm "protein restricted diet"
arm group type: Experimental
description: 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.
intervention type: Dietary Supplement
intervention name: iso-caloric ketogenic diet
description: 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
arm group label: specific diet arm "Ketogenic arm"
intervention type: Dietary Supplement
intervention name: protein restricted diet
description: 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.
arm group label: specofoc diet arm "protein restricted diet"
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Veronique D'HONDT, MD
role: Study Chair
affiliation: ICM Val d'Aurelle
last name: Aurore Moussion
phone: 04 67 61 31 02
phone ext: +33
email: DRCI-icm105@icm.unicancer.fr
last name: Emmanuelle Texier
phone: 04 67 61 31 02
phone ext: +33
email: DRCI-icm105@icm.unicancer.fr
facility: 
status: Recruiting
contact: 
country: France
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.
PMID: 22237782
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. Erratum In: CA Cancer J Clin. 2013 May;63(3):215.
PMID: 22539238
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.
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responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No