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Breast NeoplasmsNCT00522262

Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial

A study testing Aerobic exercise intervention in people with Breast Neoplasms, run by AHS Cancer Control Alberta at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 74 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Neoplasms
What is being tested?
Aerobic exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
2 sitesCanada
Study dates
Jun 2002to Jul 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female
  • Age 50-74 at baseline
  • Postmenopausal
  • Moderately sedentary lifestyle
  • Live in Calgary or Edmonton, Alberta, Canada
  • English-speaking
Show all 9Show fewer
  • Willing to be randomized
  • Body-mass index 22.0-40.0
  • Breast tissue density >=0%

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Alberta Cancer Board

    Calgary, Alberta, T2N 4N2

  • University of Alberta

    Edmonton, Alberta, T6G 2H9

Other trials in Canada

About this study

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.

Read the detailed description

The goal of this study is to examine how a one-year exercise intervention, as compared to a usual sedentary lifestyle, influences specific biologic mechanisms that are hypothesized to be operative in the association between physical activity and breast cancer risk. These biologic mechanisms include sex hormone concentrations (estrone, estradiol and sex-hormone binding globulin); measures of adiposity and obesity; mammographic density; insulin-like growth factors; and insulin resistance.

A two-centered, two-armed randomized controlled trial (RCT) of exercise and risk factors for breast cancer will be conducted. Approximately 334 postmenopausal, sedentary women will be recruited to the study. Participants will be randomized to one of two groups: an exercise intervention, or a control group. The intervention group will undertake five weekly exercise sessions of 60 minutes each; three will be facility-based and two will be home-based each week. The Edmonton and Calgary exercise oncology facilities will be working in collaboration, and each will include both the controls and exercise intervention arms of the trial. The exercise intervention will last for 12 months. The control group will be asked not to change their usual level of activity during that time.

Baseline assessments will be obtained of serum sex hormones (estrone and estradiol), measures of obesity and adiposity, mammographic density, serum insulin growth factor (IGF)-1, insulin resistance, aerobic capacity, and psychosocial health measures. At the end of the study, all baseline assessments will be repeated and compared between the two groups.

This study will specifically address identified gaps in knowledge, in terms of examining the simultaneous effect of physical activity on several biologic mechanisms in a controlled trial setting, building on evidence from the only other randomized controlled trial on this topic. Strengths of the proposal include the multi-centered setting (utilizing facilities in both Calgary and Edmonton), and the collaboration of an experienced multi-disciplinary research team from across North America.

Being tested
Aerobic exercise intervention
Keywords
Breast Neoplasms, Exercise, Physical activity, Estrone, Estradiol, Adiposity, Breast density, Mammographic density, Insulin-Like Growth Factor I, Insulin Resistance, Women, Postmenopause
Medical subject headings
Breast Neoplasms, Motor Activity, Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise interventionBehavioural

    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.

Study groups in NCT00522262
Study groupRoleWhat they receive
ExerciseExperimentalWomen randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week.
Receives: Behavioral: Aerobic exercise intervention
ControlNo interventionWomen 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Changes in mammographic density, insulin resistance and inflammatory markers

    The effect of the exercise intervention after one year is examined.

    Measured: Up to 12 months

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

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2007 (estimated)
  2. Study startJun 2002
  3. Primary completionJun 2006
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522262
Sponsor's protocol ID
16649
Status last verified
Jan 2015
First submitted
27 Aug 2007
Last updated
15 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20159820

  • 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.

    PubMed 29953441

  • 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.

    PubMed 28360432

  • 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.

    PubMed 27900199

  • 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.

    PubMed 25940342

  • 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.

    PubMed 23605145

  • 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.

    PubMed 21982875

  • 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.

    PubMed 21070806

  • 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.

    PubMed 20332266

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise intervention in people with Breast Neoplasms, run by AHS Cancer Control Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in estrone, estradiol and adiposity levels (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00522262, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.

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