此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Evaluation of Nutrition and Metabolism in Breast Cancer Patients

2015年11月4日 更新者:University of Waterloo
With the increased success in breast cancer therapies, survivors develop unhealthy changes in body composition, such as muscle loss and fat gains, which lead to increased risk of cardiovascular disease and diabetes in survivorship. This study will examine the effects of a nutrition, cardiovascular and strength exercise program compared with a yoga program (representing usual care) on body composition and metabolism in recently diagnosed breast cancer patients. Nutrition and exercise may improve various body composition and metabolic parameters, which may improve quality of life in survivorship, reduce risk of recurrence and reduce the risk of developing cardiovascular disease and diabetes in survivorship.

研究概览

详细说明

Despite the increased success of novel anti-neoplastic therapies, breast cancer patients receiving chemotherapy develop unfavourable changes in body composition, including lean tissue loss and fat gains (1,2). These detrimental changes associate with poor quality of life (3,4) and may lead to treatment complications (5,6) during the cancer trajectory. In non-malignant populations, fat gain and muscle loss associate with increased risk of cardiovascular disease and diabetes (7). Cancer survivors who gain fat and lose lean mass are not only predisposed to these diseases but also have an increased risk of cancer recurrence (3). Proper nutrition as well as exercise can independently improve metabolic profiles (i.e. immune function, lipid and glucose metabolism) and overall health outcomes in non-malignant populations (7-9). While exercise has enhanced quality of life in breast cancer patients (4), overall nutritional needs and the metabolic benefits of exercise are unclear in this patient group. Understanding the effects of nutrition and exercise interventions in breast cancer patients will form the basis for future studies and programs that integrate nutrition, exercise, and metabolism to reduce cancer recurrence and other morbidities in survivorship. This study will examine the effects of nutrition and exercise intervention on body composition and metabolism in recently diagnosed breast cancer patients.

研究类型

介入性

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

    • Ontario
      • Waterloo、Ontario、加拿大、N2L 3G1
        • University of Waterloo

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 及以上 (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:

  • Females 18 years old or older
  • Recent diagnosis of breast cancer and up to 4 weeks following the first cycle of chemotherapy or up to the first 4 weeks of radiation therapy
  • Clinical Stages I-IIIa
  • Able to communicate freely in English
  • Have sufficient cognitive ability to participate and provide informed consent

Exclusion Criteria:

  • Any known diagnosis of cardiovascular disease and thyroid disease that is not currently managed with medication or other therapies
  • Any known diagnosis of diabetes or HIV
  • Pre-existing injuries or health conditions that prevents the patient's safe participation in exercise
  • Any previous diagnosis of cancer within the last 5 years (other than carcinoma in situ)
  • Fasting glucose >7.0 mM at baseline of the study
  • Pregnant individuals will be excluded from this 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

  • 主要用途:支持治疗
  • 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
安慰剂比较:Yoga and Stretching Group
Patients undergo yoga and stretching exercises
Patients randomized to this arm will receive consultations on yoga and stretching exercises.
其他名称:
  • Minimal Exercise
有源比较器:Nutrition and Exercise Group
Patients are provided with nutrition, cardiovascular exercise and strength exercise consultations
Patients randomized to this arm will receive nutrition and exercise consultations. Exercise consultations will home- and institution-based.
其他名称:
  • Nutrition and Exercise Training

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
Change in glucose parameters from baseline
大体时间:Baseline, 8 weeks, 16 weeks
Oral glucose tolerance tests will be performed at each assessment. Changes from baseline will be measured.
Baseline, 8 weeks, 16 weeks

次要结果测量

结果测量
大体时间
Change in lipid profile relative to baseline
大体时间:Baseline, 8 weeks, 16 weeks
Baseline, 8 weeks, 16 weeks

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。

调查人员

  • 首席研究员:Marina Mourtzakis, PhD、University of Waterloo

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

2012年2月1日

初级完成 (预期的)

2015年6月1日

研究完成 (预期的)

2015年9月1日

研究注册日期

首次提交

2012年2月20日

首先提交符合 QC 标准的

2012年2月24日

首次发布 (估计)

2012年3月2日

研究记录更新

最后更新发布 (估计)

2015年11月5日

上次提交的符合 QC 标准的更新

2015年11月4日

最后验证

2015年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 17215
  • 2011-0463 (其他标识符:Tri-Hospital Research Ethics Board)

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.

订阅