Trial Studying the Feasibility of a Diet Modification in pAtients With Luminal Early Breast Cancer Candidate for Primary Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
control arm
In the control arm, patients will continue their usual diet without further recommendation.
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.
干预措施: iso-caloric ketogenic diet (Dietary Supplement)
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.
干预措施: protein restricted diet (Dietary Supplement)
结局指标
主要结局
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
时间窗: 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
次要结局
- evaluation of the impact of the patient's anxiety and depression level on the compliance to the proposed diet(From the inclusion visit until the Day 45 post surgery)
- evaluation of patient's tolerability to those diet modifications, in terms of weight status(From the inclusion visit until the Day 45 post surgery)
- evaluation of patient's tolerability to those diet modifications, in terms of adverse events(From the inclusion visit until the Day 45 post surgery)
- assessment of the acceptance of study participation and reasons for refusal(During 45 days before the surgery)
- determination of the impact of diet modification on patient's quality of life(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.(From the inclusion visit until the Day 45 post surgery)
- study of the molecular consequences of diet modifications on cancer cells and their microenvironment(At the inclusion visit and the day of surgery)