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

August 27, 2007
January 14, 2015
June 2002
June 2006   (final data collection date for primary outcome measure)
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.
  • - To examine the effect of the exercise intervention on estrone, estradiol and adiposity
  • - To examine the effect of the exercise intervention on mammographic density, insulin-like growth factors, and insulin resistance
Complete list of historical versions of study NCT00522262 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - To describe the effects of the exercise intervention on quality of life among the participants
  • - To describe the rates and determinants of recruitment and adherence to the exercise trial
Not Provided
Not Provided
 
Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial
Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Neoplasms
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.
  • Experimental: Exercise
    Women randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week.
    Intervention: Behavioral: Aerobic exercise intervention
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
July 2007
June 2006   (final data collection date for primary outcome measure)

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
Female
50 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00522262
16649
No
Christine Friedenreich, AHS Cancer Control Alberta
AHS Cancer Control Alberta
  • Canadian Breast Cancer Research Alliance
  • University of Alberta
  • University of Calgary
Principal Investigator: Christine M Friedenreich, PhD Alberta Health Services
AHS Cancer Control Alberta
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP