Clinical trial · Interventional
Exercise Program in Cancer and Cognition
Influence of Exercise on Neurocognitive Function in Breast Cancer
NCT02793921CI-TRIAL-00074394EPICCcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderate-Intensity Aerobic Exercise Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Moderate-intensity aerobic exercise
- description
- Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention.
- interventionNames
- Behavioral: Moderate-Intensity Aerobic Exercise Intervention
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Primary outcomes (1)
- measure
- Change in Cognitive Function
- timeFrame
- Baseline to 6 months
- description
- Cognitive function was assessed with a battery of 14 measures. A data reduction technique, exploratory factor analysis with principal component extraction and varimax (orthogonal) rotation, was used to create summary factors. The cognitive factors identified included processing speed, attention, mental flexibility, working memory, learning and memory, verbal memory, and executive function were derived via this factor analysis. Individual measures with the highest loadings were included in each factor. All measures had factor loadings \>0.400. Scores from the individual measures for each factor were normed based on healthy controls of similar age and education to yield a z-score and these were summed to yield an average z-score for each factor. Z-scores range from -4 to +4, where higher z-scores indicate better performance for each factor.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Postmenopausal female 2. Maximum age 80 years 3. Able to speak and read English 4. Minimum completion of 8 years of education 5. Diagnosed with Stage 0, 1, 2 or 3a Breast Cancer 6. Within 2 years post-completion of primary treatment 7. 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: 1\. 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: 1\. Presence of metal implants (i.e., pacemaker, some stents)
References
Publications (5)
- DERIVEDGentry AL, Sereika SM, Erickson KI, McCall MK, Belcher SM, Cummings MC, Cho MG, Brufsky E, Rosenzweig MQ, Bender CM. The relationship of neighborhood socioeconomic disadvantage and pretreatment cancer-related cognitive impairment in women with breast cancer: A post hoc analysis of a randomized controlled trial. Cancer. 2026 Jul 15;132(14):e70506. doi: 10.1002/cncr.70506. PMID 42421660
- DERIVEDLiu S, Liu D, Bender CM, Erickson KI, Sereika SM, Shaffer JR, Weeks DE, Conley YP. DNA methylation associations with cognitive function in early-stage hormone receptor-positive breast cancer patients. Epigenomics. 2025 Sep;17(13):879-889. doi: 10.1080/17501911.2025.2542116. Epub 2025 Aug 6. PMID 40768266
- DERIVEDBender CM, Sereika SM, Gentry AL, Zhu Y, Wagner M, Cuglewski C, Duquette J, Grove G, Cummings M, Cho MG, Brufsky AM, Diego EJ, McAuliffe PF, Marsland AL, Conley YP, Erickson KI. Aerobic exercise and aromatase inhibitor-associated musculoskeletal symptoms: results of a randomized clinical trial. Support Care Cancer. 2025 Mar 4;33(3):244. doi: 10.1007/s00520-025-09257-4. PMID 40035875
- DERIVEDBender CM, Sereika SM, Gentry AL, Duquette JE, Casillo FE, Marsland A, Brufsky AM, Evans S, Gorantla VC, Grahovac TL, McAuliffe PF, Steiman JG, Zhu Y, Erickson KI. Physical activity, cardiorespiratory fitness, and cognitive function in postmenopausal women with breast cancer. Support Care Cancer. 2021 Jul;29(7):3743-3752. doi: 10.1007/s00520-020-05865-4. Epub 2020 Nov 19. PMID 33210238
- DERIVEDGentry AL, Erickson KI, Sereika SM, Casillo FE, Crisafio ME, Donahue PT, Grove GA, Marsland AL, Watt JC, Bender CM. Protocol for Exercise Program in Cancer and Cognition (EPICC): A randomized controlled trial of the effects of aerobic exercise on cognitive function in postmenopausal women with breast cancer receiving aromatase inhibitor therapy. Contemp Clin Trials. 2018 Apr;67:109-115. doi: 10.1016/j.cct.2018.02.012. Epub 2018 Mar 6. PMID 29501739