Exercise Program in Cancer and Cognition (EPICC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02793921|
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Moderate-Intensity Aerobic Exercise Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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)
- 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.
- Pro-inflammatory cytokines [ Time Frame: Baseline and 6 months ]
- 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.
- 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.
- Estradiol (E2) levels [ Time Frame: Baseline and 6 months ]
- 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.
- Anxiety [ Time Frame: Baseline and 6 months ]The Anxiety 8a PROMIS short form will be used to measure anxiety.
- Sleep problems [ Time Frame: Baseline and 6 months ]Sleep problems will be measured using SenseWear physical activity-monitoring armband.
- Sleep problems [ Time Frame: Baseline and 6 months ]Sleep problems will be measured using the Pittsburgh Sleep Quality Index.
- Sleep problems [ Time Frame: Baseline and 6 months ]Sleep problems will be measured using the Epworth Sleepiness Scale.
- Depressive symptoms [ Time Frame: Baseline and 6 months ]Depressive symptoms will be measured using the Beck Depression Inventory II.
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
|Contact: Amanda L Gentry, MPHemail@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Amanda L Gentry, MPH 412-624-6950 firstname.lastname@example.org|
|Principal Investigator:||Catherine M Bender, PhD||University of Pittsburgh|
|Principal Investigator:||Kirk I Erickson, PhD||University of Pittsburgh|