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NCT Number: NCT07587957

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

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).

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location status: Recruiting

Location contact

Ashley L Artese, PhD

CONTACT

[email protected]

856-534-8926

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise + transcranial alternating current stimulation (Ex+tACS)

Behavioral

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).

Control

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley L Artese, PhD

CONTACT

[email protected]

856-534-8926

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Collaborators

  • Florida Department of Health
  • Memorial Sloan Kettering Cancer Center

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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