Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Changes in estrone, estradiol and adiposity levels
研究概览
简要总结
The purpose of the ALPHA Trial is to examine the physiologic changes that occur in a woman's body when she begins exercising that may be related to a change in her risk of getting breast cancer.
详细描述
The goal of this study is to examine how a one-year exercise intervention, as compared to a usual sedentary lifestyle, influences specific biologic mechanisms that are hypothesized to be operative in the association between physical activity and breast cancer risk. These biologic mechanisms include sex hormone concentrations (estrone, estradiol and sex-hormone binding globulin); measures of adiposity and obesity; mammographic density; insulin-like growth factors; and insulin resistance.
A two-centered, two-armed randomized controlled trial (RCT) of exercise and risk factors for breast cancer will be conducted. Approximately 334 postmenopausal, sedentary women will be recruited to the study. Participants will be randomized to one of two groups: an exercise intervention, or a control group. The intervention group will undertake five weekly exercise sessions of 60 minutes each; three will be facility-based and two will be home-based each week. The Edmonton and Calgary exercise oncology facilities will be working in collaboration, and each will include both the controls and exercise intervention arms of the trial. The exercise intervention will last for 12 months. The control group will be asked not to change their usual level of activity during that time.
Baseline assessments will be obtained of serum sex hormones (estrone and estradiol), measures of obesity and adiposity, mammographic density, serum insulin growth factor (IGF)-1, insulin resistance, aerobic capacity, and psychosocial health measures. At the end of the study, all baseline assessments will be repeated and compared between the two groups.
This study will specifically address identified gaps in knowledge, in terms of examining the simultaneous effect of physical activity on several biologic mechanisms in a controlled trial setting, building on evidence from the only other randomized controlled trial on this topic. Strengths of the proposal include the multi-centered setting (utilizing facilities in both Calgary and Edmonton), and the collaboration of an experienced multi-disciplinary research team from across North America.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 50-74 at baseline
- •Postmenopausal
- •Moderately sedentary lifestyle
- •Live in Calgary or Edmonton, Alberta, Canada
- •English-speaking
- •Willing to be randomized
- •Body-mass index 22.0-40.0
- •Breast tissue density >=0%
排除标准
- •Previous invasive cancer in last 5 years
- •Major co-morbidities
- •Unable to participate in exercise program
- •Current smoker
- •Current excessive drinker
- •Hormone replacement therapy use in previous 2 years
- •Drugs that may influence one or more study outcomes
结局指标
主要结局
Changes in estrone, estradiol and adiposity levels
时间窗: Up to 12 months
The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined.
次要结局
- Changes in mammographic density, insulin resistance and inflammatory markers(Up to 12 months)
- The effect of the exercise intervention on exercise adherence and quality of life.(Up to 12 months)
研究者
Christine Friedenreich
Scientific Leader and Principal Investigator
AHS Cancer Control Alberta