Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Aerobic exercise intervention
Intervention type(s): Behavioral
Intervention description(s): Women in the exercise arm underwent a year-long exercise intervention of five days per week of 45 minutes/session of moderate-vigorous intensity aerobic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast Neoplasms; Exercise; Physical activity; Estrone; Estradiol; Adiposity; Breast density; Mammographic density; Insulin-Like Growth Factor I; Insulin Resistance; Women; Postmenopause