Breast Cancer and Exercise Trial in Alberta (BETA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by AHS Cancer Control Alberta.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rachel Syme, Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01435005
First received: August 30, 2011
Last updated: January 18, 2012
Last verified: September 2011
  Purpose

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 a women's risk for breast cancer, particularly 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


Condition Intervention Phase
Breast Neoplasms
Other: Volume of Exercise; Moderate or High Volume
Other: Aerobic Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Breast Cancer and Exercise Trial in Alberta: The BETA Trial

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
    Measurements taken of Insulin Levels, Glucose Levels, Insulin Resistance (HOMA Score)


Secondary Outcome Measures:
  • Body Fat [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Body composition will include: weight, height, body mass index, waist circumference, waist-hip ratio, total body fat, subcutaneous fat, intra-abdominal fat, lean body mass

  • Sex Hormone Levels [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measure levels of Estrone, Estradiol, Androstenedione and Testosterone

  • Biomarkers of Obesity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measuring weight, height, body mass index, waist circumference, waist-hip ratio, total body fat, subcutaneous fat, intra-abdominal fat, lean body mass

  • Inflammation [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Measure levels of C-Reative protein, Interleukin-6 and Tumour necrosis factor.


Estimated Enrollment: 400
Study Start Date: March 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Participate in one year of moderate volume (300 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment.
Other: Volume of Exercise; Moderate or High Volume
What volume of exercise will better reduce breast cancer risk in postmenopausal women.
Other: Aerobic Exercise
Participate in one-year high volume (300 minutes per week)aerobic exercise.
Active Comparator: Arm B
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: Volume of Exercise; Moderate or High Volume
What volume of exercise will better reduce breast cancer risk in postmenopausal women.
Other: Aerobic Exercise
moderate volume (150 minutes per week) aerobic exercise

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435005

Contacts
Contact: Sarah MacLaughlin, B.A, MSc. 403-521-3847 Sarah.MacLaughlin@albertahealthservices.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Sarah MacLaughlin    403-521-3847    Sarah.MacLaughlin@albertahealthservices.ca   
Principal Investigator: Christine M Friedenreich, BSc MSc PhD         
Cross Cancer Centre Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Amy E Speed-Andrews, MSc PhD    780-492-2663    speedand@ualberta.ca   
Principal Investigator: Kerry S Courneya, BSc, MSc, PhD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Christine Friedenreich, BSc, MSc,PhD Tom Baker Cancer Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Rachel Syme, Dr. Christine Friedenreich - Study Principle Investigator, Alberta Health Services
ClinicalTrials.gov Identifier: NCT01435005     History of Changes
Other Study ID Numbers: ACF:24404
Study First Received: August 30, 2011
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Prevention and control
Exercise
Sedentary lifestyle
Biological markers

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014