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Exercise Program in Cancer and Cognition (EPICC)

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ClinicalTrials.gov Identifier: NCT02793921
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Catherine M. Bender, PhD, RN, FAAN, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Moderate-Intensity Aerobic Exercise Intervention Not Applicable

Detailed Description:

The specific aims include:

  1. Compared to usual care, examine whether the 6-month exercise intervention improves cognitive function in postmenopausal women with early stage breast cancer.

    Hypothesis 1. Exercise will improve cognitive function in women in a domain specific fashion such that attention, executive and memory functions will be influenced more than other domains.

  2. 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 as primary outcomes; TNF-α as secondary), and explore the direct effects of exercise on symptoms (fatigue, sleep problems, depression, anxiety).

    Hypothesis 2. Exercise will improve neuroimaging metrics of brain health and pro-inflammatory biomarkers.

  3. 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 and TNF-α levels and c) symptoms (fatigue, sleep problems, depression, anxiety), and moderated by E2 levels.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Influence of Exercise on Neurocognitive Function in Breast Cancer
Study Start Date : April 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moderate-intensity aerobic exercise
Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention.
Behavioral: Moderate-Intensity Aerobic Exercise Intervention
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).

No Intervention: Usual Care
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 Outcome Measures :
  1. Change in cognitive function [ Time Frame: Baseline and 6 months ]
    A comprehensive neuropsychological battery to assess 6 domains of cognitive function (attention, learning and memory, executive function, mental flexibility, psychomotor efficiency, visuospatial ability)


Secondary Outcome Measures :
  1. Neuroimaging metrics of brain health [ Time Frame: Baseline and 6 months ]
    fMRI will be used to measure regional gray matter volume, white matter architecture and functional dynamics of the brain.

  2. Pro-inflammatory cytokines [ Time Frame: Baseline and 6 months ]
  3. Cardiovascular Fitness (submaximal VO2) [ Time Frame: Baseline and 6 months ]
    Fitness will be measured by submaximal VO2 test. The submaximal test is similar to the full test, but stops at 85% of the age-predicted heart rate. The protocol involves walking at a self-selected pace between 2.0-4.0 mph with increasing grade increments of 2% every two minutes. The test is terminated when the subject reaches 85% of their age-predicted heart rate or at volitional exhaustion.

  4. Energy expenditure (SenseWear physical activity-monitoring armband) [ Time Frame: Baseline, 3.5 months and 7 months ]
    Energy expenditure will be measured using SenseWear physical activity-monitoring armbands. This armband is worn around the upper arm (left triceps) for 1 week at a time.

  5. Estradiol (E2) levels [ Time Frame: Baseline and 6 months ]
  6. Fatigue [ Time Frame: Baseline and 6 months ]
    The Fatigue 8a Patient Reported Outcomes Measurement Information System (PROMIS) short form will be used to measure fatigue.

  7. Anxiety [ Time Frame: Baseline and 6 months ]
    The Anxiety 8a PROMIS short form will be used to measure anxiety.

  8. Sleep problems [ Time Frame: Baseline and 6 months ]
    Sleep problems will be measured using SenseWear physical activity-monitoring armband.

  9. Sleep problems [ Time Frame: Baseline and 6 months ]
    Sleep problems will be measured using the Pittsburgh Sleep Quality Index.

  10. Sleep problems [ Time Frame: Baseline and 6 months ]
    Sleep problems will be measured using the Epworth Sleepiness Scale.

  11. Depressive symptoms [ Time Frame: Baseline and 6 months ]
    Depressive symptoms will be measured using the Beck Depression Inventory II.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793921


Contacts
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Contact: Amanda L Gentry, MPH 412-624-6950 amg168@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Amanda L Gentry, MPH    412-624-6950    amg168@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Catherine M Bender, PhD University of Pittsburgh
Principal Investigator: Kirk I Erickson, PhD University of Pittsburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Catherine M. Bender, PhD, RN, FAAN, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02793921    
Other Study ID Numbers: R01CA196762 ( U.S. NIH Grant/Contract )
1R01CA196762-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the completion of the intervention, after investigators have been un-blinded to group status, and after the testing and publication of the primary aims and hypotheses, the investigators will provide de-identified data to interested investigators provided that they closely consult with Drs. Bender and Erickson with respect to study design, analytical procedures, and to avoid overlapping research in analyses or manuscript preparation. The primary investigative team will be given priority in addressing scientific questions of interest with the collected data, but will work closely with any interested investigators in maximizing the data to address other questions of interest that could be answered by these data.
Keywords provided by Catherine M. Bender, PhD, RN, FAAN, University of Pittsburgh:
Alteration
Cognitive Function
Exercise
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases