Study on Physical Activity's Relationship With Cancer and Cognition

Breast Cancer Clinical Trial

— SPARCC  

Official title:

Study on Physical Activity's Relationship With Cancer and Cognition: A Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980626
• Other study ID #: 0091-19-FB
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). Participants will be randomized to a 12-week walking intervention or usual care. Walking participants will attend small group sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist. All participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI). The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue.

Description:

Aim 1: This pilot study tests the effects of aerobic exercise training on cognitive function in breast cancer survivors (BCS). To test aim 1, the investigators will randomize up to forty post-menopausal BCS (3-24 months post-treatment) to a 12-week walking intervention (n=20) or usual care (n=20). Walking participants will attend small group (n=3-5 BCS) sessions led by an exercise specialist 3 times weekly. Usual care participants will complete baseline and post-testing and be offered two sessions with an exercise specialist after all data have been collected. Aim 1 measures include accelerometry, neurocognitive testing, and patient-reported outcomes at baseline and post-intervention. Aim 2: The investigators will generate preliminary data on clinical and biological correlates of exercise and cognition, including treatment protocol, cardiorespiratory fitness, brain structure and function, and cancer-related fatigue. To test aim 2, all participants will complete a fitness test, electrophysiology, and patient-reported outcomes at baseline and post-intervention. A subset of participants will also be invited to undergo magnetic resonance imaging (MRI). Data will be analyzed using descriptive statistics and analysis of covariance, and effect sizes expressed as standard mean difference will be calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female
• Post-menopausal at time of diagnosis
• First, primary diagnosis of Stage I-IIIa breast cancer
• Completed treatment 3-24 months prior to study start
• Available to attend exercise sessions 3 times weekly for 12 weeks
• No scheduled travel >7 consecutive days during the intervention
• Agree to be randomized
• Willingness to wear, charge, and sync Fitbit
• English reading and speaking
• Physician's clearance to exercise
• Provide written informed consent

Exclusion Criteria:

• Males
• Pre- or peri-menopausal at the time of diagnosis
• Stage 0 or metastatic disease
• Currently receiving chemotherapy or radiation therapy
• More than 24 months post-treatment
• Scheduled to receive breast surgery
• Second cancer diagnosis (excluding non-invasive skin cancers)
• Self-report an average of =60 minutes of MVPA per week for the previous 6 months
• Not cleared to exercise by a physician
• Not available to attend 3 times weekly exercise sessions for 12 weeks
• Out of town travel scheduled for >1 week during the intervention
• Unwilling to complete baseline assessments
• Unwilling to be randomized to the exercise or control group
• Unwilling to wear, charge, and sync the Fitbit during the study period
• Unable to read and speak in English
• Unwilling to provide written informed consent to participate
• Cognitive impairment prior to baseline assessment
• History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Behavioral:
• Walking
The exercise intervention is designed to improve cardiorespiratory fitness, a known correlate of cognition and brain health, and follows the American College of Sports Medicine exercise guidelines for cancer survivors. Participants will engage in small group, moderate-to-vigorous intensity walking sessions three times weekly. Sessions will begin with a warm-up and end with a cool down and be progressive in nature. Volume of exercise will increase across weeks such that participants will progress from 15-20 minutes of walking to 40-45 minutes by week 8, and from 40-55% of their estimated heart rate reserve (HRR) to 65% of their HRR by week 9. All sessions will be led by trained exercise specialists to ensure close monitoring of participant safety. Participants will wear heart rate monitors and be asked to rate their perceived exertion to ensure they are exercising within the prescribed range. Modifications to each participant's exercise prescription will be made as needed.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Executive Function	A comprehensive neurocognitive battery will be administered to measure executive function as defined by a latent factor of manifest indicators of performance on executive function tasks.	Baseline, Week 12
Primary	Change in Working Memory	A comprehensive neurocognitive battery will be administered to measure working memory as defined by a latent factor of manifest indicators of performance on working memory tasks.	Baseline, Week 12
Primary	Change in Processing Speed	A comprehensive neurocognitive battery will be administered to measure processing speed as defined by a latent factor of manifest indicators of processing speed tasks.	Baseline, Week 12
Secondary	Regional brain volume	Magnetic Resonance Imaging (MRI) will be used to measure regional volume.	Baseline, Week 12
Secondary	White matter structural integrity	Diffusion tensor imaging (DTI) will be used to measure white matter structural integrity (fractional anisotropy, diffusivity).	Baseline, Week 12
Secondary	Resting state functional connectivity	Resting state function MRI will be used to measure resting state functional connectivity (patterns of blood oxygen level dependent (BOLD) activity within seed regions of interest compared to whole brain activity).	Baseline, Week 12
Secondary	N2pc Amplitude	N2pc amplitude is a neural measure of spacial attention during the Visual Search Task (measured in microvolts) to be measured with electroencephalography (Visual Search Task, Change Detections Task).	Baseline, Week 12
Secondary	Cardiorespiratory Fitness	Fitness will be measured with a submaximal exercise test. The Naughton Protocol for submaximal graded exercise tests will be used to examine change in cardiovascular fitness.	Baseline, Week 12
Secondary	Cancer-related Fatigue	The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.	Baseline, Week 12
Secondary	Objective Activity Behavior	Objective activity behavior (average minutes per day) will be measured using actigraphy.	Baseline, Week 12