Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Breast Cancer and Exercise Trial in Alberta

NCT01435005

Breast Neoplasms

COMPLETED NA

Exercise in Women at Risk for Breast Cancer

NCT00092950

Breast Neoplasms

COMPLETED PHASE2

Physical Activity for Adults in the Ontario Breast Screening Program

NCT06405568

Breast Cancer Female Physical Inactivity

NOT_YET_RECRUITING NA

Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors

NCT04965246

Inflammation Cognitive Impairment Anxiety +1 more

COMPLETED NA

Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

NCT00253916

Prostatic Neoplasms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise

Women randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week.

Group Type EXPERIMENTAL

Aerobic exercise intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes