Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Aerobic exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Women randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week. | Behavioral: Aerobic exercise intervention<br>* 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.<br>|
| No Intervention: Control<br>Women randomized to the control arm were asked to maintain their regular lifestyle which meant no changes to their exercise or dietary intake. Women eligible for this trial were inactive and hence were expected not to increase their levels of physical activity in the control arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in estrone, estradiol and adiposity levels | The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mammographic density, insulin resistance and inflammatory markers | The effect of the exercise intervention after one year is examined. | Up to 12 months | 
| The effect of the exercise intervention on exercise adherence and quality of life. |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Estrone, Breast Neoplasms, Exercise, Physical activity, Estradiol, Adiposity, Breast density, Mammographic density, Insulin-Like Growth Factor I, Insulin Resistance, Women, Postmenopause