Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

Breast Neoplasms Clinical Trial

Official title:

Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522262
• Other study ID #: 16649
• Status: Completed
• Phase: N/A
• First received: August 27, 2007
• Last updated: January 14, 2015
• Start date: June 2002
• Est. completion date: July 2007

Study information

• Verified date: January 2015
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: July 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Alberta Cancer Board	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Canadian Breast Cancer Research Alliance, University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Friedenreich CM, Woolcott CG, McTiernan A, Ballard-Barbash R, Brant RF, Stanczyk FZ, Terry T, Boyd NF, Yaffe MJ, Irwin ML, Jones CA, Yasui Y, Campbell KL, McNeely ML, Karvinen KH, Wang Q, Courneya KS. Alberta physical activity and breast cancer prevention — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in mammographic density, insulin resistance and inflammatory markers	The effect of the exercise intervention after one year is examined.	Up to 12 months	No
Secondary	The effect of the exercise intervention on exercise adherence and quality of life.		Up to 12 months	No