Exercise Program in Cancer and Cognition

NCT02793921 | Completed Results DMC

• 2 other identifiers: STUDY190802231R01CA196762-01A1
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Alteration; Cognitive Function; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function

  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.

  Baseline to 6 months

Secondary Outcomes (8)

• Total Brain Size

  Baseline and 6 months

• Pro-inflammatory Cytokines

  Baseline to 6 months

• Peak VO2

  Baseline and 6 months

• Estradiol (E2) Levels

  Baseline to 6 months

• Fatigue

  Baseline and 6 months

Other Outcomes (4)

• Change in White Matter Microstructure

  Baseline and 6 months

• Changes in Prefrontal Cortex

  Baseline and 6 months

• Changes in Task-evoked Functional MRI Outcomes

  Baseline and 6 months

Study Arms (2)

Moderate-intensity aerobic exercise

EXPERIMENTAL

Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention.

Behavioral: Moderate-Intensity Aerobic Exercise Intervention

Usual Care

NO INTERVENTION

Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.

Interventions

Moderate-Intensity Aerobic Exercise Intervention BEHAVIORAL

The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).

Moderate-intensity aerobic exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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
• \. Presence of metal implants (i.e., pacemaker, some stents)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (4)

• Liu 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 DERIVED

• Bender 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 DERIVED

• Bender 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 DERIVED

• Gentry 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Results Point of Contact

• Title: Dr. Catherine Bender, Principal Investigator
• Organization: University of Pittsburgh

cbe100@pitt.edu

412-624-3594

Study Officials

• Catherine M Bender, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kirk I Erickson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 8, 2016
• Study Start: April 1, 2016
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)