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

Primary Purpose

Breast Cancer, Surgery

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

iso-caloric ketogenic diet

protein restricted diet

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring dietary survey,

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Icm Val D'AurelleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

control arm

specific diet arm "Ketogenic arm"

specofoc diet arm "protein restricted diet"

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Weight surveillance (in kilograms)

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

monitoring of adverse events related to diet (with CTCAE (Common Terminology Criteria for Adverse Events) version 5.0)

assessment of the acceptance of study participation and reasons for refusal

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

determination of the impact of diet modification on patient's quality of life

Result of the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire

evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.

Result of the questionnaire of Beliefs about diet and cancer OPINELE (Opinions concernant l'alimentation, la santé et le cancer)

evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet

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

Full Information

NCT ID

NCT04469296

First Posted

July 6, 2020

Last Updated

January 6, 2023

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

1. Study Identification

Unique Protocol Identification Number

NCT04469296

Brief Title

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

Acronym

MACS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 18, 2021 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Surgery

Keywords

dietary survey,

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control arm

Arm Type

No Intervention

Arm Description

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

Arm Title

specific diet arm "Ketogenic arm"

Arm Type

Experimental

Arm Description

Arm Title

specofoc diet arm "protein restricted diet"

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

iso-caloric ketogenic diet

Intervention 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

Intervention Type

Dietary Supplement

Intervention Name(s)

protein restricted diet

Intervention 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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

during 3 days before the primary surgery

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

At the inclusion visit and the day of surgery

Title

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

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

Time Frame

At the inclusion visit and the day of surgery

Title

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

Description

Weight surveillance (in kilograms)

Time Frame

From the inclusion visit until the Day 45 post surgery

Title

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

Description

monitoring of adverse events related to diet (with CTCAE (Common Terminology Criteria for Adverse Events) version 5.0)

Time Frame

From the inclusion visit until the Day 45 post surgery

Title

assessment of the acceptance of study participation and reasons for refusal

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

Time Frame

During 45 days before the surgery

Title

determination of the impact of diet modification on patient's quality of life

Description

Result of the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) questionnaire

Time Frame

From the inclusion visit until the Day 45 post surgery

Title

evaluation of the impact of patient's beliefs about diet and cancer on the compliance to the proposed diet.

Description

Result of the questionnaire of Beliefs about diet and cancer OPINELE (Opinions concernant l'alimentation, la santé et le cancer)

Time Frame

From the inclusion visit until the Day 45 post surgery

Title

evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet

Description

Time Frame

From the inclusion visit until the Day 45 post surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aurore Moussion

Phone

04 67 61 31 02

Ext

+33

DRCI-icm105@icm.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Emmanuelle Texier

Phone

04 67 61 31 02

Ext

+33

DRCI-icm105@icm.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronique D'HONDT, MD

Organizational Affiliation

ICM Val d'Aurelle

Official's Role

Study Chair

Facility Information:

Facility Name

Icm Val D'Aurelle

City

Montpellier

State/Province

Herault

ZIP/Postal Code

34298

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Veronique D'HONDT, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22237782

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.

Results Reference

result

PubMed Identifier

22539238

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.

Results Reference

result

PubMed Identifier

28457987

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.

Results Reference

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PubMed Identifier

28187287

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.

Results Reference

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PubMed Identifier

27653140

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.

Results Reference

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PubMed Identifier

25815989

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.

Results Reference

result

PubMed Identifier

25502434

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.

Results Reference

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PubMed Identifier

28539118

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.

Results Reference

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PubMed Identifier

31399389

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.

Results Reference

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PubMed Identifier

20318124

Citation

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

Results Reference

result

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

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