Breast Cancer and Exercise Trial in Alberta (BETA)

January 27, 2018 updated by: Christine Friedenreich, AHS Cancer Control Alberta

Breast Cancer and Exercise Trial in Alberta: The BETA Trial

The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at understanding what dose (or volume) of exercise will best reduce the risk for breast cancer, particularly among women who are between the ages of 50-74. The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Overview The proposed project is an evolution from a previous randomized controlled intervention trial conducted by the applicants known as the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial that examined how a one-year aerobic exercise intervention, as compared to a usual sedentary lifestyle, influenced specific hypothesized biologic mechanisms in the association between physical activity and breast cancer risk. In the proposed project, we plan to extend this research to examine how a one-year high versus moderate volume aerobic exercise intervention influences established and novel biologic mechanisms thought to influence breast cancer risk. We are specifically interested in studying what dose of exercise is required to influence the biologic mechanisms involved in breast cancer etiology.

Rationale and Significance Inadequate physical activity, high total caloric intake, and obesity, central adiposity and weight gain throughout lifetime are all clearly associated with increased postmenopausal breast cancer risk and are some of the few risk factors amenable to intervention. Over one third of breast cancer can be attributed to these three risk factors. The exact dose and type of physical activity required for breast cancer risk reduction, however, are unknown. No trials have been conducted that have systematically examined how different volumes of activity influence mechanisms in breast cancer etiology.

Study Aims The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific hormonal and biological intermediate endpoints for breast cancer in a group of previously sedentary postmenopausal women. The primary objectives will examine the effects of the interventions on measures of adiposity, insulin resistance, sex hormone levels, markers of obesity and inflammation and serum vitamin D. The secondary aim is to evaluate the impact of the high versus moderate exercise interventions among postmenopausal, sedentary women on psychosocial factors. The secondary objectives will compare the effects of the exercise interventions on quality of life and perceived stress among the participants. Adherence to the exercise intervention at 12 and maintenance of exercise at 24 months will also be assessed.

Research Plan A two-centered, two-armed randomized controlled trial is proposed. In total, 330 postmenopausal, sedentary women aged 50-74 years will be recruited from the screening programs and through media campaigns. Strict eligibility criteria will be applied to ensure that women enrolled in the study can be expected to have a change in breast cancer risk over the one-year long intervention. Randomization will be stratified on centre (Calgary or Edmonton) and on body mass index (< or ≥27.5). The intervention arm will undertake aerobic exercise sessions of 300 mins/week for 12 months. The control arm will be asked to undertake 150 mins/week for 12 months. Baseline and 12-month measurements of adiposity (done by computerized tomography and dual energy X-ray absorbitometry scans), fitness, diet, physical activity, quality of life and stress, determinants of exercise adherence and medical, health and demographic characteristics will be made. Bloods, drawn at baseline, six and 12 months, will be assayed to measure estrone, estradiol, testosterone, androstenedione, insulin, glucose, adiponectin, leptin, interleukin-6, tumour necrosing factor-alpha, C-reactive protein and serum hydroxyvitamin D. One year after completion of the study, maintenance of physical and dietary habits will be measured. Intent-to-treat analysis will be used with a Laird-Ware mixed effects model to compare the changes from the baseline to 12-month follow-up. These data will be of direct relevance for effectiveness trials of exercise and diet for breast cancer prevention and for refinement of physical activity guidelines.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: 50- 74 years, postmenopausal women
  • No previous cancer diagnosis
  • Physically fit to undertake exercise program
  • Pass the Physical Activity Readiness
  • Medical Exam,acceptable heart and lung function during a sub-maximal treadmill test
  • Body mass index : 22 - 40
  • Non-users of exogenous hormones or drugs related to estrogen metabolism, breast tissue growth
  • Non-Smoker and non-excessive alcohol drinkers
  • Residents of Calgary and Edmonton able to attend fitness facility regularly.

Exclusion Criteria:

  • < 50 years of age
  • Diabetes
  • Deemed too fit or too unfit on sub-maximal treadmill test
  • Non English Speaking
  • > 4 consecutive weeks absence during the intervention period

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High Volume
Participate in one year of high volume (300 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment.
Other: High Volume
Participate in one-year high volume (300 minutes per week)aerobic exercise.
Active Comparator: Moderate Volume
Participate in one year of moderate volume (150 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment.
Other: Moderate Volume
Moderate volume (150 minutes per week) aerobic exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Fat
Time Frame: 36 Months
Body composition (including weight, hip circumference, waist circumference, waist-hip ratio, total body fat, subcutaneous fat, intra-abdominal fat, lean body mass, body mass index)
36 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: 36 months
Measurements taken of Insulin Levels, Glucose Levels, Insulin Resistance (HOMA Score)
36 months
Sex Hormone Levels
Time Frame: 36 months
Measure levels of Estrone, Estradiol, Androstenedione and Testosterone
36 months
Inflammation
Time Frame: 36 months
Measure levels of C-Reactive protein, Interleukin-6 and Tumour necrosis factor.
36 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AHS Cancer Control Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Friedenreich, PhD, Tom Baker Cancer Centre

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACF:24404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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