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Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy (PASAPAS)

2014年10月29日 更新者:Centre Leon Berard

Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

研究概览

详细说明

With approximately 52,600 new cases diagnosed in France in 2010, breast cancer is the most common cancer in women, according to national projections of the incidence and cancer mortality for 2010.

Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity).

Several hypotheses explain the association between obesity and breast cancer: obesity, metabolic syndrome and diabetes participate to changes in hormone levels (estrogen, leptin, insulin) that promotes mammary carcinogenesis and tumor progression.

The association between obesity and development of breast cancer is partly due to increased serum levels of estradiol produced by adipocytes, but the role of insulin resistance and inflammation associated with obesity is widely discussed.

Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Thus, several large cohort studies of women with breast cancer showed an average mortality reduction of 45% associated with moderate physical activity compared with inactivity. Adapted Physical Activity (APA) could also improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

A rich fruits and vegetables diet combined with regular physical activity appears to offer the best protection from breast cancer. The nature, frequency, duration, intensity and arrangement of physical training program meetings are key elements to consider, metabolic responses differ according to these factors.

The optimal management for an improved level of physical activity appear to be an individual of at least three sessions per week, 30 to 60 minutes each with a moderate intensity, allowing a physiological response to chronic exercise and an adequate recovery.

After diagnosis of breast cancer, there is thus many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lyon Cedex 08、法国、69373
        • Centre Léon Bérard

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female, 18 years ≤ age < 75 years
  • With an invasive, non-metastatic, histologically confirmed, first breast carcinoma
  • Requiring the prescription of a first line of adjuvant chemotherapy
  • Followed in the research center
  • Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician, the referring physician or the physician investigator
  • Residing within a radius of 60 km around the center investigator or agreeing to bear the travel costs beyond proposed reimbursement
  • Availability and willingness to invest in the PASAPAS study during the program (6 months) and during the post-program follow-up (6 months)
  • Able to understand, read and write French
  • Covered by a medical insurance
  • Written, signed informed consent

Exclusion Criteria:

  • Female with metastatic or inflammatory breast cancer,
  • History or concomitant primary cancer (except for carcinoma in situ of the uterine cervix and/or skin basal cell carcinoma and or colon carcinoma in situ and/or not a breast cancer in complete response for at least 5 years)
  • Cons-indication to physical activity practice, at discretion of the investigator,
  • In a state of severe malnutrition according to the criteria of the High Authority for Health (HAS) 2010, namely:

    • Among women ≤ 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month
    • Among women > 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month, body mass index < 18 kg / m²
  • History of eating disorders,
  • Not possible follow-up for medical, social, familial, geographical or psychological reasons, during the program (6 months) and during the post-program follow-up (6 months),
  • Deprived of their liberty by court or administrative decision,
  • Pregnant or nursing, of childbearing age without effective contraception during the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Control arm
Dietetic follow-up only
Dietetic follow-up only
实验性的:Intervention arm
Dietetic + adapted physical activity
Dietetic follow up + adapted physical activity
其他名称:
  • APA arm

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment in a cohort of adult patients with a 1st breast cancer non-metastatic, the feasibility of implementing an APA intervention during 6 months, in addition to a dietary management, concomitant to prescription of a first-line adjuvant chemotherapy
大体时间:6 months
Proportion of patients who participate in at least two mandatory APA sessions by week during all the APA program, except during the 1st week of each course of CT
6 months

次要结果测量

结果测量
措施说明
大体时间
Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance
大体时间:6 months
Rate of patients who completed the full program and analysis of non-compliance grounds during the program
6 months
Assessment of acceptability of the intervention and randomization / recruiting capabilities
大体时间:6 months
Number of patients contacted by the investigator to participate in the study and rate of patients randomized
6 months
Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions
大体时间:12 months
Formalization of a program used in real conditions
12 months
Description of patient satisfaction
大体时间:Month 12
Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction
Month 12
Medico-economic impact of the intervention
大体时间:12 months
Settlement expenses costs, incurred costs and costs avoided by the intervention
12 months
Biological study
大体时间:Day 1 CT, week 9, week 24, month 12
Analyses of metabolomic profiles and adipokines expression linked to breast cancer at initial diagnosis (before surgery) and description of metabolism changes during nutritional interventions and therapeutic care
Day 1 CT, week 9, week 24, month 12
Description of dietary
大体时间:Day 1 CT, week 24, month 12
Collection of patient nutritional intake during 3 days by self-administered questionnaire
Day 1 CT, week 24, month 12
Description of level and pattern physical activity
大体时间:Day 1 CT, Week 9, Week 24, Month 12
Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)
Day 1 CT, Week 9, Week 24, Month 12
Description of anthropometry
大体时间:Day 1 CT, week 9, week 24, month 12
Measurement of weight, height, waist and hip circumference
Day 1 CT, week 9, week 24, month 12
Description of lipid profiles
大体时间:Day 1 CT, week 9, week 24, month 12
Measurement of total cholesterol, HDL, LDL and triglycerides
Day 1 CT, week 9, week 24, month 12
Assessment of life quality
大体时间:Day 1 CT, week 24, month 12
Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)
Day 1 CT, week 24, month 12
Description of anxiety
大体时间:Day 1 CT, week 24, month 12
score calculation of anxiety (STAI questionnaire)
Day 1 CT, week 24, month 12
Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance
大体时间:6 months
Rate of patients who completed the full program and analysis of non-compliance grounds during the program
6 months
Description of body satisfaction
大体时间:Day 1 CT, week 24, month 12
score calculation of QSCPGS questionnaire
Day 1 CT, week 24, month 12
Description of body composition
大体时间:Day 1 CT, week 9, week 24, month 12
Measurement of body composition by impedancemetry
Day 1 CT, week 9, week 24, month 12
Description of self-perception
大体时间:Day 1 CT, week 24, month 12
score calculation of self-perception (QSCPGS questionnaire)
Day 1 CT, week 24, month 12
Description of self esteem
大体时间:Day 1 CT, week 24, month 12
score calculation of self-esteem (Rosenzweig scale)
Day 1 CT, week 24, month 12
Description of depression
大体时间:Day 1 CT, week 24, month 12
score calculation of depression (BDI questionnaire)
Day 1 CT, week 24, month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年7月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2011年4月4日

首先提交符合 QC 标准的

2011年4月7日

首次发布 (估计)

2011年4月8日

研究记录更新

最后更新发布 (估计)

2014年10月30日

上次提交的符合 QC 标准的更新

2014年10月29日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • PASAPAS
  • 2011-A00064-37 (其他标识符:AFSSAPS)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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