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Exercise Program in Cancer and Cognition (EPICC)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate-Intensity Aerobic Exercise Intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring Alteration, Cognitive Function, Exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Moderate-intensity aerobic exercise

Usual Care

Arm Description

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

Outcomes

Primary Outcome Measures

Change in cognitive function
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

Neuroimaging metrics of brain health
fMRI will be used to measure regional gray matter volume, white matter architecture and functional dynamics of the brain.
Pro-inflammatory cytokines
Cardiovascular Fitness (submaximal VO2)
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.
Energy expenditure (SenseWear physical activity-monitoring armband)
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.
Estradiol (E2) levels
Fatigue
The Fatigue 8a Patient Reported Outcomes Measurement Information System (PROMIS) short form will be used to measure fatigue.
Anxiety
The Anxiety 8a PROMIS short form will be used to measure anxiety.
Sleep problems
Sleep problems will be measured using SenseWear physical activity-monitoring armband.
Sleep problems
Sleep problems will be measured using the Pittsburgh Sleep Quality Index.
Sleep problems
Sleep problems will be measured using the Epworth Sleepiness Scale.
Depressive symptoms
Depressive symptoms will be measured using the Beck Depression Inventory II.

Full Information

First Posted
May 20, 2016
Last Updated
January 10, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02793921
Brief Title
Exercise Program in Cancer and Cognition
Acronym
EPICC
Official Title
Influence of Exercise on Neurocognitive Function in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The specific aims include: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Alteration, Cognitive Function, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate-intensity aerobic exercise
Arm Type
Experimental
Arm Description
Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention.
Arm Title
Usual Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Aerobic Exercise Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in cognitive function
Description
A comprehensive neuropsychological battery to assess 6 domains of cognitive function (attention, learning and memory, executive function, mental flexibility, psychomotor efficiency, visuospatial ability)
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Neuroimaging metrics of brain health
Description
fMRI will be used to measure regional gray matter volume, white matter architecture and functional dynamics of the brain.
Time Frame
Baseline and 6 months
Title
Pro-inflammatory cytokines
Time Frame
Baseline and 6 months
Title
Cardiovascular Fitness (submaximal VO2)
Description
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.
Time Frame
Baseline and 6 months
Title
Energy expenditure (SenseWear physical activity-monitoring armband)
Description
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.
Time Frame
Baseline, 3.5 months and 7 months
Title
Estradiol (E2) levels
Time Frame
Baseline and 6 months
Title
Fatigue
Description
The Fatigue 8a Patient Reported Outcomes Measurement Information System (PROMIS) short form will be used to measure fatigue.
Time Frame
Baseline and 6 months
Title
Anxiety
Description
The Anxiety 8a PROMIS short form will be used to measure anxiety.
Time Frame
Baseline and 6 months
Title
Sleep problems
Description
Sleep problems will be measured using SenseWear physical activity-monitoring armband.
Time Frame
Baseline and 6 months
Title
Sleep problems
Description
Sleep problems will be measured using the Pittsburgh Sleep Quality Index.
Time Frame
Baseline and 6 months
Title
Sleep problems
Description
Sleep problems will be measured using the Epworth Sleepiness Scale.
Time Frame
Baseline and 6 months
Title
Depressive symptoms
Description
Depressive symptoms will be measured using the Beck Depression Inventory II.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine M Bender, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirk I Erickson, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33210238
Citation
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.
Results Reference
derived
PubMed Identifier
29501739
Citation
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.
Results Reference
derived

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Exercise Program in Cancer and Cognition

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