Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

This study has been completed.
Sponsor:
Collaborators:
Canadian Breast Cancer Research Alliance
University of Alberta
University of Calgary
Information provided by (Responsible Party):
Christine Friedenreich, AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00522262
First received: August 27, 2007
Last updated: January 14, 2015
Last verified: January 2015
  Purpose

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 Intervention
Breast Neoplasms
Behavioral: Aerobic exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Changes in estrone, estradiol and adiposity levels [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined.


Secondary Outcome Measures:
  • Changes in mammographic density, insulin resistance and inflammatory markers [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The effect of the exercise intervention after one year is examined.

  • The effect of the exercise intervention on exercise adherence and quality of life. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: June 2002
Study Completion Date: July 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522262

Locations
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
Investigators
Principal Investigator: Christine M Friedenreich, PhD AHS Cancer Control Alberta
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christine Friedenreich, Scientific Leader and Principal Investigator, AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00522262     History of Changes
Other Study ID Numbers: 16649
Study First Received: August 27, 2007
Last Updated: January 14, 2015
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Breast Neoplasms
Exercise
Physical activity
Estrone
Estradiol
Adiposity
Breast density
Mammographic density
Insulin-Like Growth Factor I
Insulin Resistance
Women
Postmenopause

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2015