N/A
N=153
Exercise Program in Cancer and Cognition
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02793921 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Cognitive Function — -0.05; 0.01; 0.21; 0.17 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Moderate-Intensity Aerobic Exercise Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function |
-0.05; 0.01; 0.21; 0.17; -0.05; -0.07 | — |
| SECONDARY Total Brain Size |
1026742.118; 1044057.647; 1033171.625; 1058477.167 | — |
| SECONDARY Pro-inflammatory Cytokines |
0.47; 0.45; 0.07; 0.09 | — |
| SECONDARY Peak VO2 |
17.31; 17.72; 18.44; 19.74 | — |
| SECONDARY Estradiol (E2) Levels |
0.48; 0.67 | — |
| SECONDARY Fatigue |
18.60; 18.90; 17.81; 16.83 | — |
| SECONDARY Anxiety |
1.85; 1.55 | — |
| SECONDARY Sleep Problems |
12.21; 13.36 | — |
| SECONDARY Depressive Symptoms |
5.51; 5.27 | — |
Summary
This randomized control trial will examine whether a well-controlled and monitored exercise intervention improves cognitive function in postmenopausal women with early-stage breast cancer and will explore whether neuroimaging metrics of brain health, pro-inflammatory biomarkers and symptoms (fatigue, sleep problems, depression, anxiety) mediate the effects of exercise on cognitive function. Furthermore, the study will explore whether the magnitude of the improvements in cognitive function are modified by estradiol levels.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal female
- Maximum age 80 years
- Able to speak and read English
- Minimum completion of 8 years of education
- Diagnosed with Stage 0, 1, 2 or 3a Breast Cancer
- Within 2 years post-completion of primary treatment
- At least two weeks post-breast conserving surgery or three weeks post-breast conserving surgery with sentinel lymph node biopsy or four weeks post-mastectomy
Exclusion Criteria
- Prior treatment with cancer chemotherapy, central nervous system radiation, or intrathecal therapy 2. Clinical evidence of distant metastases 3. Self-report of hospitalization for psychiatric illness within the last two years 4. History of neurologic illness 5. Any of the following breast cancer surgery complications unless approved by the participant's health care provider: persistent seroma requiring aspiration, wound dehiscence, infection, prolonged drain output, lymphedema 6. Reconstructive surgery unless approved by the participant's health care provider 7. Any significant medical condition that would preclude them from exercising (e.g., uncontrolled diabetes, congestive heart failure, angina, uncontrolled arrhythmia or other symptoms that indicate increased risk for an acute cardiovascular or respiratory event) If necessary, we will verify this information with a participant's health care provider 8. Eating disorders or a history of substance abuse 10. Any use of an assisted walking device 11. Recent history of falls or balance problems
Additional Exclusion Criteria for Neuroimaging subgroup:
- Presence of metal implants (i.e., pacemaker, some stents)
Data sourced from ClinicalTrials.gov (NCT02793921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.