This randomized clinical trial studies how well aerobic exercise works in improving cognitive function in patients with stage 0-IIIA breast cancer. An aerobic exercise program may improve cognitive function (the ability to maintain attention and remember things) during therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT02793921.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. Compared to usual care, examine whether the 6-month exercise intervention improves cognitive function over the first six months of aromatase inhibitor (AI) therapy in postmenopausal women with early stage breast cancer.
II. Compared to usual care, examine the direct effects of exercise on neuroimaging metrics of brain health including regional gray matter volume, white matter architecture and functional dynamics of the brain and the pro-inflammatory biomarkers (IL-6 and CRP as primary outcomes; TNF-alpha as secondary), and explore the direct effects of exercise on symptoms (fatigue, sleep problems, depression, anxiety).
III. Compared to usual care, explore whether the effects of exercise on cognitive function are mediated by a) neuroimaging metrics of cognitive function, b) IL-6, CRP and TNF-alpha levels and c) symptoms (fatigue, sleep problems, depression, anxiety), and moderated by E2 levels over the first six months of AI therapy.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients start by exercising over 10-15 minutes 3 days per weeks at weeks 1-2 and gradually increase the duration at weeks 3-6 until they reach 40–50 minutes per session/3 days per week. This level is then maintained for up to 6 months.
GROUP II: Patients receive standard of care.
After completion of study intervention, patients are followed up at approximately 1 month.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorCatherine Bender