Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
研究概览
详细说明
Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued:
- To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence
- To assess the impact of the weight loss interventions on quality of life and sleep
- To assess the impact of weight loss on measures of bone health
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- postmenopausal (defined as experiencing at least 12 months without a menstrual period)
- diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation
- completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment
- BMI ≥ 27 kg/m2
- less than 7 servings of alcohol per week
- willing to be randomized into either group
- not planning to move away from the area during the period of study
- non-smoker
Exclusion Criteria:
- serious illness requiring medical treatment
- inability to participate in physical activity due to severe disability
- history of schizophrenia, psychosis or untreated major depression
- unwilling to commute to study site once per week
- failure to provide written informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 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 |
|---|---|
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实验性的：Calorie restricted diet plus exercise
See Intervention Description
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Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
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有源比较器：Weight management classes
See Intervention Description
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Weekly 1-hour weight management classes for 12 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in body weight
大体时间：0, 6, 12, 18 weeks
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0, 6, 12, 18 weeks
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合作者和调查者
调查人员
- 首席研究员：Susan Raatz, PhD, MPH, RD、USDA Grand Forks Human Nutrition Research Center
- 首席研究员：Mindy S Kurzer, PhD, MPH, RD、University of Minnesota
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.
Calorie restricted diet plus exercise的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的