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Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

50 Years
74 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

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 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.

Inclusion Criteria:

- Female

- 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%

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To examine the effect of the exercise intervention on estrone, estradiol and adiposity

Principal Investigator

Christine M Friedenreich, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:




Start Date:

June 2002

Completion Date:

July 2007

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Exercise
  • Physical activity
  • Estrone
  • Estradiol
  • Adiposity
  • Breast density
  • Mammographic density
  • Insulin-Like Growth Factor I
  • Insulin Resistance
  • Women
  • Postmenopause
  • Breast Neoplasms
  • Neoplasms