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Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00522262
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : January 15, 2015
Canadian Breast Cancer Research Alliance
University of Alberta
University of Calgary
Information provided by (Responsible Party):
Christine Friedenreich, AHS Cancer Control Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Aerobic exercise intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial
Study Start Date : June 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise
Women randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week.
Behavioral: Aerobic exercise intervention
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.

No Intervention: Control
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.

Primary Outcome Measures :
  1. Changes in estrone, estradiol and adiposity levels [ Time Frame: Up to 12 months ]
    The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined.

Secondary Outcome Measures :
  1. Changes in mammographic density, insulin resistance and inflammatory markers [ Time Frame: Up to 12 months ]
    The effect of the exercise intervention after one year is examined.

  2. The effect of the exercise intervention on exercise adherence and quality of life. [ Time Frame: Up to 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00522262

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Canada, Alberta
Alberta Cancer Board
Calgary, Alberta, Canada, T2N 4N2
University of Alberta
Edmonton, Alberta, Canada, T6G 2H9
Sponsors and Collaborators
AHS Cancer Control Alberta
Canadian Breast Cancer Research Alliance
University of Alberta
University of Calgary
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Principal Investigator: Christine M Friedenreich, PhD Alberta Health Services
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Christine Friedenreich, Scientific Leader and Principal Investigator, AHS Cancer Control Alberta Identifier: NCT00522262    
Other Study ID Numbers: 16649
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Christine Friedenreich, AHS Cancer Control Alberta:
Breast Neoplasms
Physical activity
Breast density
Mammographic density
Insulin-Like Growth Factor I
Insulin Resistance
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases