Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery (MACS)
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|ClinicalTrials.gov Identifier: NCT04469296|
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : September 16, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Surgery||Dietary Supplement: iso-caloric ketogenic diet Dietary Supplement: protein restricted diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2022|
No Intervention: control arm
In the control arm, patients will continue their usual diet without further recommendation.
Experimental: specific diet arm "Ketogenic arm"
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.
Dietary Supplement: 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 well as a low glycemic index food composition table centered on carbohydrates for better control of food choice
Experimental: specofoc diet arm "protein restricted diet"
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.
Dietary Supplement: 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.
- 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 ]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
- 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 ]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 [ Time Frame: At the inclusion visit and the day of surgery ]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 [ Time Frame: From the inclusion visit until the Day 45 post surgery ]Weight surveillance (in kilograms)
- 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 ]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 [ Time Frame: During 45 days before the surgery ]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 [ Time Frame: From the inclusion visit until the Day 45 post surgery ]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. [ Time Frame: at the inclusion visit ]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 [ Time Frame: From the inclusion visit until the Day 45 post surgery ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469296
|Contact: jean-Pierre Bleuse, MD||04 67 61 31 02 ext +33||DRCIemail@example.com|
|Contact: Emmanuelle Texier||04 67 61 31 02 ext +33||DRCIfirstname.lastname@example.org|
|Icm Val D'Aurelle|
|Montpellier, Herault, France, 34298|
|Contact: Veronique D'HONDT, MD|
|Study Chair:||Veronique D'HONDT, MD||ICM Val d'Aurelle|