Exploring the Feasibility of an Exercise and Noninvasive Brain Stimulation Intervention in Breast Cancer Survivors

May 7, 2026 updated by: Florida Atlantic University
The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in breast cancer survivors who report experiencing cancer-related cognitive impairment. Feasibility will be assessed by measuring participant retention, adherence, satisfaction with the intervention, and safety. The researchers will also examine pre-to-post intervention changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is one of the most common forms of cancer among women in the United States. Although advances in cancer treatments have led to improved survival rates, breast cancer survivors must contend with the negative side effects from the cancer and its treatments. One of the most common and highly distressing treatment side effects is cancer-related cognitive impairment (CRCI), which is characterized by losses in memory, attention, processing speed, and executive function, which make daily tasks such as recalling information, organizing daily routines, concentrating, and multitasking more challenging. Findings from previous studies support aerobic exercise training as an effective strategy for improving cognitive function. In addition, non-invasive brain stimulation (NIBS), a technique in which electrodes are applied to the skin to noninvasively stimulate specific regions of the brain, has also been found to be a safe and effective approach for improving cognitive outcomes. Among various NIBS techniques, transcranial alternating current stimulation (tACS), which delivers current to the brain in an alternating pattern, may be a promising strategy for improving cognitive outcomes. Few studies have explored these approaches in breast cancer survivors, and to our knowledge, the combination of exercise and tACS (Ex+tACS) has not been explored.

This study will assess the feasibility of a 4-week Ex+tACS intervention in breast cancer survivors who report cancer-related cognitive impairment. Researchers will also examine changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ashley L Artese, PhD
  • Phone Number: 856-534-8926
  • Email: aartese@fau.edu

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Recruiting
        • Florida Atlantic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Breast cancer survivors (≥18 years) will be eligible to participate if the following inclusion criteria is met:
  • Diagnosed non-metastatic breast cancer (stages 0-3)
  • Completed primary breast cancer treatment (surgery, chemotherapy, radiation) for at least 3 months
  • Self-reported cognitive impairment after cancer treatment

Exclusion Criteria:

  • Current participation in aerobic exercise for ≥60 min/wk
  • Contraindication or impairment that precludes the potential participant from exercise as defined by the American College of Sports Medicine
  • The presence of serious medical illnesses, metal implants, previous brain trauma, epilepsy or history of seizures, previous surgery to the head or spinal cord, or skin problems at the forehead area where the tACS electrodes will be applied
  • Uncontrolled cardiovascular disease
  • Functional impairments or physical condition that would make exercise unsafe
  • Metastatic cancer or diagnosis of a different cancer (excluding melanoma) within the past 5 years
  • Contraindication to exercise a defined by the American College of Sports Medicine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
The Exercise + transcranial alternating current stimulation (Ex+tACS) group will complete a four-week intervention consisting of 3 days/week of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS. During tACS, 6Hz alternating current stimulation will be administered to participants' prefrontal cortex (forehead region) using a tACS while the participant completes the AX Continuous Performance Test (AX-CPT).
Behavioral: Exercise + transcranial alternating current stimulation (Ex+tACS)
The Ex+tACS group will complete a four-week intervention consisting of 3 days/week of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS while completing the AX Continuous Performance Test (AX-CPT).
Sham Comparator: Control
The Sham Comparator group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham transcranial alternating current stimulation (tACS) condition. The same procedures will be followed regarding the tACS, but stimulation will only last one minute, ramping up and down at the beginning and end of the 15-minute period, simulating the periodic tingling sensation that are reported with tACS.
Behavioral: Control
The Control (CON) group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham tACS condition. After each session, both the EX+tACS and control participants will complete a questionnaire regarding experience with tACS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: From baseline to the end of the 4-week intervention
Adherence will be calculated based on the percentage of prescribed sessions attended and percentage of participants who complete the prescribed exercise and tACS sessions.
From baseline to the end of the 4-week intervention
Retention
Time Frame: From baseline to the end of the 4-week intervention
Retention will be determined by the number of enrolled breast cancer survivors who participate in the four-week intervention and complete post assessments.
From baseline to the end of the 4-week intervention
Acceptability
Time Frame: From baseline to the end of the 4-week intervention
Acceptability will be determined by the percentage of participants who report satisfaction with the intervention.
From baseline to the end of the 4-week intervention
Safety (Adverse Events)
Time Frame: From baseline to the end of the 4-week intervention
Safety (<5% of serious adverse events) will be determined by the percentage of participants experiencing a serious adverse event related to the program.
From baseline to the end of the 4-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained attention
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT).
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Executive function
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in executive function, measured by performance (time) on the Trail Making Test Part A (TMT-A) and Part B (TMT-B).
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Inhibitory control
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Working Memory
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Subjective Cognition
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in subjective cognition, measured by the Functional Assessment Cancer Therapy-Cognition (FACT-COG)
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Physical Function
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in lower body physical function, measured by the 30-second chair stand.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Cardiorespiratory endurance
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in cardiorespiratory fitness, measured by the six-minute walk test.
Baseline, within 2 weeks following the intervention, and 4-week follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat percentage
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in body fat percentage measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Learning and Memory
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in learning and memory, assessed by the California Verbal Learning Test.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Quality of Life (FACT-B)
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in quality of life, measured by the Functional Assessment of Cancer Therapy - Breast. Scores range from 0-148, with higher scores indicating better quality of life.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Fatigue (FACIT-F)
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in fatigue, measured by the Functional Assessment of Chronic Illness Therapy-Fatigue. Scores range from 0-52, with higher scores indicating less fatigue.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Perceived exercise benefits and barriers
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in perceived benefits and barriers to exercise, measured by the Exercise Benefits/Barriers Scale (EBBS). Benefit scores range from 29-116, with higher scores indicating greater perceived benefits. Barrier scores range from 14-56, with higher scores indicating greater perceived barriers.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Physical Function (Short Physical Performance Battery)
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in physical function, assessed using the Short Physical Performance Battery. Scores range from 0-12, with higher scores indicating better physical function.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Muscle Power
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in lower body muscle power, measured by a single sit-to-stand using the Tendo Power Analyzer.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Grip strength
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in grip strength, measured using a hand-held grip strength dynamometer
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Upper body physical function
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in upper body physical function, measured by the 30-second arm curl test.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Fall Risk
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in fall risk, measured by the Falls Efficacy Scale. Scores range from 16-64, with higher scores indicating greater fall risk.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Physical Activity
Time Frame: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in physical activity, measured by an accelerometer.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Skeletal Muscle
Time Frame: Baseline, within two weeks following the intervention, 4-week follow-up
Description: Researchers will assess pre- to post-intervention changes in skeletal muscle (kg) measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device
Baseline, within two weeks following the intervention, 4-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Atlantic University

Collaborators

Memorial Sloan Kettering Cancer Center
Florida Department of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2507199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The dissemination plan includes sharing de-identified data for external researchers.

IPD Sharing Time Frame

IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for 2027.

IPD Sharing Access Criteria

Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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