Aerobic Exercise in Improving Cognitive Function in Patients with Stage 0-IIIA Breast Cancer
- Postmenopausal women, defined by lack of a menstrual period for an entire year
- Able to speak and read English
- Completed a minimum of 8 years of education
- Diagnosed with stage 0, I, II, or IIIa breast cancer, confirmed by medical record
- Eligible to receive, but not yet begun, aromatase inhibitor therapy
- Will be two weeks post-breast conserving surgery or three weeks post-breast conserving surgery with sentinel lymph node biopsy or four weeks post-mastectomy at the start of participation
- Prior diagnoses of any other type of cancer (excluding some skin cancers)
- Clinical evidence of metastatic disease
- Any of the following breast cancer surgery complications; persistent seroma requiring aspiration, wound dehiscence, infection, prolonged drain output, lymphedema
- Reconstructive surgery
- Any significant medical condition that would preclude them from exercising (e.g., congestive heart failure, angina, uncontrolled arrhythmia or other symptoms that indicate increased risk for an acute cardiovascular or respiratory event)
- Self-report of hospitalization for psychiatric illness within the last two years
- History of neurologic illness such as stroke, multiple sclerosis, multi-infarct dementia, or Parkinson’s disease or history of dementia or chronic fatigue syndrome
- Any use of an assisted walking device
- Eating disorders
- History of substance abuse
- Recent history of falls or balance problems
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 Phase Phase NA
Trial Type Supportive care
University of Pittsburgh Cancer Institute (UPCI)
- Primary ID 16-057
- Secondary IDs NCI-2017-01818
- Clinicaltrials.gov ID NCT02793921