Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

January 14, 2015 updated by: Christine Friedenreich, AHS Cancer Control Alberta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Alberta Cancer Board
      • Edmonton, Alberta, Canada, t6g 2h9
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
The effect of the exercise intervention on exercise adherence and quality of life.
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

University of Alberta
University of Calgary
Canadian Breast Cancer Research Alliance

Investigators

  • Principal Investigator: Christine M Friedenreich, PhD, Alberta Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (ESTIMATE)

August 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16649 (Other Identifier: NSD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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