NCT00522262

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2002

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

June 1, 2002

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

4 years

First QC Date

August 27, 2007

Last Update Submit

January 14, 2015

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmsExercisePhysical activityEstroneEstradiolAdiposityBreast densityMammographic densityInsulin-Like Growth Factor IInsulin ResistanceWomenPostmenopause

Outcome Measures

Primary Outcomes (1)

  • Changes in estrone, estradiol and adiposity levels

    The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined.

    Up to 12 months

Secondary Outcomes (2)

  • Changes in mammographic density, insulin resistance and inflammatory markers

    Up to 12 months

  • The effect of the exercise intervention on exercise adherence and quality of life.

    Up to 12 months

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Aerobic exercise intervention

Control

NO INTERVENTION

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.

Interventions

Aerobic exercise interventionBEHAVIORAL

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.

Exercise

Eligibility Criteria

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

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alberta Cancer Board

Calgary, Alberta, T2N 4N2, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2H9, Canada

Location

Related Publications (9)

  • Friedenreich CM, Woolcott CG, McTiernan A, Ballard-Barbash R, Brant RF, Stanczyk FZ, Terry T, Boyd NF, Yaffe MJ, Irwin ML, Jones CA, Yasui Y, Campbell KL, McNeely ML, Karvinen KH, Wang Q, Courneya KS. Alberta physical activity and breast cancer prevention trial: sex hormone changes in a year-long exercise intervention among postmenopausal women. J Clin Oncol. 2010 Mar 20;28(9):1458-66. doi: 10.1200/JCO.2009.24.9557. Epub 2010 Feb 16.

    PMID: 20159820RESULT

  • Boyne DJ, King WD, Brenner DR, McIntyre JB, Courneya KS, Friedenreich CM. Aerobic exercise and DNA methylation in postmenopausal women: An ancillary analysis of the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial. PLoS One. 2018 Jun 28;13(6):e0198641. doi: 10.1371/journal.pone.0198641. eCollection 2018.

    PMID: 29953441DERIVED

  • 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

  • Friedenreich CM, Pialoux V, Wang Q, Shaw E, Brenner DR, Waltz X, Conroy SM, Johnson R, Woolcott CG, Poulin MJ, Courneya KS. Effects of exercise on markers of oxidative stress: an Ancillary analysis of the Alberta Physical Activity and Breast Cancer Prevention Trial. BMJ Open Sport Exerc Med. 2016 Oct 24;2(1):e000171. doi: 10.1136/bmjsem-2016-000171. eCollection 2016.

    PMID: 27900199DERIVED

  • Aparicio-Ting FE, Farris M, Courneya KS, Schiller A, Friedenreich CM. Predictors of physical activity at 12 month follow-up after a supervised exercise intervention in postmenopausal women. Int J Behav Nutr Phys Act. 2015 May 5;12:55. doi: 10.1186/s12966-015-0219-z.

    PMID: 25940342DERIVED

  • Woolcott CG, Courneya KS, Boyd NF, Yaffe MJ, McTiernan A, Brant R, Jones CA, Stanczyk FZ, Terry T, Cook LS, Wang Q, Friedenreich CM. Association between sex hormones, glucose homeostasis, adipokines, and inflammatory markers and mammographic density among postmenopausal women. Breast Cancer Res Treat. 2013 May;139(1):255-65. doi: 10.1007/s10549-013-2534-x. Epub 2013 Apr 21.

    PMID: 23605145DERIVED

  • Friedenreich CM, Neilson HK, Woolcott CG, Wang Q, Stanczyk FZ, McTiernan A, Jones CA, Irwin ML, Yasui Y, Courneya KS. Inflammatory marker changes in a yearlong randomized exercise intervention trial among postmenopausal women. Cancer Prev Res (Phila). 2012 Jan;5(1):98-108. doi: 10.1158/1940-6207.CAPR-11-0369. Epub 2011 Oct 7.

    PMID: 21982875DERIVED

  • Courneya KS, Tamburrini AL, Woolcott CG, McNeely ML, Karvinen KH, Campbell KL, McTiernan A, Friedenreich CM. The Alberta Physical Activity and Breast Cancer Prevention Trial: quality of life outcomes. Prev Med. 2011 Jan;52(1):26-32. doi: 10.1016/j.ypmed.2010.10.014. Epub 2010 Nov 8.

    PMID: 21070806DERIVED

  • Woolcott CG, Courneya KS, Boyd NF, Yaffe MJ, Terry T, McTiernan A, Brant R, Ballard-Barbash R, Irwin ML, Jones CA, Brar S, Campbell KL, McNeely ML, Karvinen KH, Friedenreich CM. Mammographic density change with 1 year of aerobic exercise among postmenopausal women: a randomized controlled trial. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1112-21. doi: 10.1158/1055-9965.EPI-09-0801. Epub 2010 Mar 23.

    PMID: 20332266DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor ActivityObesityInsulin Resistance

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Christine M Friedenreich, PhD

    Alberta Health services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Leader and Principal Investigator

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 29, 2007

Study Start

June 1, 2002

Primary Completion

June 1, 2006

Study Completion

July 1, 2007

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

CA(2)