Breast Cancer and Exercise Trial in Alberta (BETA)
This study is currently recruiting participants.
Verified September 2011 by Alberta Health Services
Sponsor:
Alberta Health Services
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
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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 Alberta Health Services:
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
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
Alberta Health Services
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 Alberta Health Services:
|
Prevention and control Exercise Sedentary lifestyle Biological markers |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013