NCT01435005

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

August 30, 2011

Last Update Submit

January 27, 2018

Conditions

Breast Neoplasms

Keywords

Prevention and controlExerciseSedentary lifestyleBiological markers

Outcome Measures

Primary Outcomes (1)

  • Body Fat

    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 Outcomes (3)

  • Insulin resistance

    36 months

  • Sex Hormone Levels

    36 months

  • Inflammation

    36 months

Study Arms (2)

High Volume

ACTIVE COMPARATOR

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

Moderate Volume

ACTIVE COMPARATOR

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

Interventions

Moderate VolumeOTHER

Moderate volume (150 minutes per week) aerobic exercise

Moderate Volume
High VolumeOTHER

Participate in one-year high volume (300 minutes per week)aerobic exercise.

High Volume

Eligibility Criteria

Age50 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Centre

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Publications (11)

  • Gonzalo-Encabo P, McNeil J, Perez-Lopez A, Valades D, Courneya KS, Friedenreich CM. Weight Regain and Breast Cancer-Related Biomarkers Following an Exercise Intervention in Postmenopausal Women. Cancer Epidemiol Biomarkers Prev. 2021 Jun;30(6):1260-1269. doi: 10.1158/1055-9965.EPI-20-1652. Epub 2021 Mar 18.

    PMID: 33737300DERIVED

  • Brenner DR, Ruan Y, Adams SC, Courneya KS, Friedenreich CM. The impact of exercise on growth factors (VEGF and FGF2): results from a 12-month randomized intervention trial. Eur Rev Aging Phys Act. 2019 Jun 24;16:8. doi: 10.1186/s11556-019-0215-4. eCollection 2019.

    PMID: 31285780DERIVED

  • Friedenreich CM, Ruan Y, Duha A, Courneya KS. Exercise Dose Effects on Body Fat 12 Months after an Exercise Intervention: Follow-up from a Randomized Controlled Trial. J Obes. 2019 Jan 20;2019:3916416. doi: 10.1155/2019/3916416. eCollection 2019.

    PMID: 30805213DERIVED

  • Stone CR, Friedenreich CM, O'Reilly R, Farris MS, Vallerand JR, Kang DW, Courneya KS. Predictors of Adherence to Different Volumes of Exercise in the Breast Cancer and Exercise Trial in Alberta. Ann Behav Med. 2019 Mar 28;53(5):453-465. doi: 10.1093/abm/kay057.

    PMID: 30020401DERIVED

  • McNeil J, Farris MS, Ruan Y, Merry H, Lynch BM, Matthews CE, Courneya KS, Friedenreich CM. Effects of prescribed aerobic exercise volume on physical activity and sedentary time in postmenopausal women: a randomized controlled trial. Int J Behav Nutr Phys Act. 2018 Mar 21;15(1):27. doi: 10.1186/s12966-018-0659-3.

    PMID: 29562927DERIVED

  • Brenner DR, Ruan Y, Morielli AR, Courneya KS, Friedenreich CM. Physical activity does not alter prolactin levels in post-menopausal women: results from a dose-response randomized controlled trial. Eur Rev Aging Phys Act. 2017 Jul 13;14:10. doi: 10.1186/s11556-017-0179-1. eCollection 2017.

    PMID: 28717404DERIVED

  • McNeil J, Brenner DR, Courneya KS, Friedenreich CM. Dose-response effects of aerobic exercise on energy compensation in postmenopausal women: combined results from two randomized controlled trials. Int J Obes (Lond). 2017 Aug;41(8):1196-1202. doi: 10.1038/ijo.2017.87. Epub 2017 Mar 31.

    PMID: 28360432DERIVED

  • Courneya KS, McNeil J, O'Reilly R, Morielli AR, Friedenreich CM. Dose-Response Effects of Aerobic Exercise on Quality of Life in Postmenopausal Women: Results from the Breast Cancer and Exercise Trial in Alberta (BETA). Ann Behav Med. 2017 Jun;51(3):356-364. doi: 10.1007/s12160-016-9859-8.

    PMID: 27837524DERIVED

  • Friedenreich CM, Neilson HK, Wang Q, Stanczyk FZ, Yasui Y, Duha A, MacLaughlin S, Kallal C, Forbes CC, Courneya KS. Effects of exercise dose on endogenous estrogens in postmenopausal women: a randomized trial. Endocr Relat Cancer. 2015 Oct;22(5):863-76. doi: 10.1530/ERC-15-0243.

    PMID: 26338699DERIVED

  • Friedenreich CM, Neilson HK, O'Reilly R, Duha A, Yasui Y, Morielli AR, Adams SC, Courneya KS. Effects of a High vs Moderate Volume of Aerobic Exercise on Adiposity Outcomes in Postmenopausal Women: A Randomized Clinical Trial. JAMA Oncol. 2015 Sep;1(6):766-76. doi: 10.1001/jamaoncol.2015.2239.

    PMID: 26181634DERIVED

  • Friedenreich CM, MacLaughlin S, Neilson HK, Stanczyk FZ, Yasui Y, Duha A, Lynch BM, Kallal C, Courneya KS. Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA). BMC Cancer. 2014 Dec 6;14:919. doi: 10.1186/1471-2407-14-919.

    PMID: 25480020DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivitySedentary Behavior

Interventions

Hospitals, High-Volume

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

HospitalsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Christine Friedenreich, PhD

    Tom Baker Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Phase 3 - 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Christine Friedenreich - Study Principal Investigator

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 15, 2011

Study Start

March 1, 2010

Primary Completion

April 1, 2013

Study Completion

June 1, 2014

Last Updated

January 30, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)