Clinical Trials /

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

NCT04469296

Description:

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

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: PROICM 2019-05 MAC
  • NCT ID: NCT04469296

Conditions

  • Breast Cancer
  • Surgery

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
control armNo InterventionIn the control arm, patients will continue their usual diet without further recommendation.
    specific diet arm "Ketogenic arm"ExperimentalIn 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.
      specofoc diet arm "protein restricted diet"ExperimentalIn 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.

        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) 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.
              
        Maximum Eligible Age:80 Years
        Minimum Eligible Age:18 Years
        Eligible Gender:Female
        Healthy Volunteers:No

        Primary Outcome Measures

        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
        Safety Issue:
        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

        Secondary Outcome Measures

        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
        Safety Issue:
        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
        Safety Issue:
        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
        Safety Issue:
        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
        Safety Issue:
        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
        Safety Issue:
        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
        Safety Issue:
        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:at the inclusion visit
        Safety Issue:
        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
        Safety Issue:
        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

        Details

        Phase:N/A
        Primary Purpose:Interventional
        Overall Status:Not yet recruiting
        Lead Sponsor:Institut du Cancer de Montpellier - Val d'Aurelle

        Trial Keywords

        • dietary survey,

        Last Updated

        July 20, 2020