An interventional study of Aerobic exercise intervention in Breast Neoplasms, sponsored by AHS Cancer Control Alberta. Completed at 2 sites in Canada. Open to female participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-15.
Sponsored by AHS Cancer Control Alberta · Not applicable, Interventional, and Prevention
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.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 320 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Women randomized to the exercise intervention arm completed a one year aerobic exercise intervention of 225 minutes/week.
Behavioral: Aerobic exercise 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.
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.
Changes in estrone, estradiol and adiposity levels
The effect of the exercise intervention on sex steroid and adiposity levels after one year is examined.
Time frame: Up to 12 months
Changes in mammographic density, insulin resistance and inflammatory markers
The effect of the exercise intervention after one year is examined.
Time frame: Up to 12 months
The effect of the exercise intervention on exercise adherence and quality of life.
Time frame: Up to 12 months
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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AHS Cancer Control Alberta