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Breast CancerNCT07587957

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

A study testing Exercise + transcranial alternating current stimulation (Ex+tACS) in people with Breast Cancer, run by Florida Atlantic University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Exercise + transcranial alternating current stimulation (Ex+tACS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
7 Jan 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ashley L Artese, PhD contact

856-534-8926

aartese@fau.edu

United States1 site, 1 recruiting
  • Florida Atlantic University

    Boca Raton, Florida, 33431

    Ashley L Artese, PhD, 856-534-8926, aartese@fau.edu

    Recruiting

Other trials in United States

About this study

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).

Read the 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).

Conditions
Breast Cancer
Being tested
Exercise + transcranial alternating current stimulation (Ex+tACS), Control
Keywords
Breast Cancer, Cancer-related cognitive impairment, Non-invasive brain stimulation, Exercise
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise + transcranial alternating current stimulation (Ex+tACS)Behavioural

    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).

  • ControlBehavioural

    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.

Study groups in NCT07587957
Study groupRoleWhat they receive
Intervention ArmExperimentalThe 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).
Receives: Behavioral: Exercise + transcranial alternating current stimulation (Ex+tACS)
ControlSham comparatorThe 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.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    Adherence will be calculated based on the percentage of prescribed sessions attended and percentage of participants who complete the prescribed exercise and tACS sessions.

    Measured: From baseline to the end of the 4-week intervention

  2. Retention

    Retention will be determined by the number of enrolled breast cancer survivors who participate in the four-week intervention and complete post assessments.

    Measured: From baseline to the end of the 4-week intervention

  3. Acceptability

    Acceptability will be determined by the percentage of participants who report satisfaction with the intervention.

    Measured: From baseline to the end of the 4-week intervention

  4. Safety (Adverse Events)

    Safety (<5% of serious adverse events) will be determined by the percentage of participants experiencing a serious adverse event related to the program.

    Measured: From baseline to the end of the 4-week intervention

Secondary outcomes (7)
  1. Sustained attention

    Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT).

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

  2. Executive function

    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).

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

  3. Inhibitory control

    Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task.

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

  4. Working Memory

    Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks.

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

  5. Subjective Cognition

    Researchers will assess pre- to post-intervention changes in subjective cognition, measured by the Functional Assessment Cancer Therapy-Cognition (FACT-COG)

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

  6. Physical Function

    Researchers will assess pre- to post-intervention changes in lower body physical function, measured by the 30-second chair stand.

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

  7. Cardiorespiratory endurance

    Researchers will assess pre- to post-intervention changes in cardiorespiratory fitness, measured by the six-minute walk test.

    Measured: Baseline, within 2 weeks following the intervention, and 4-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start7 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587957
Sponsor's protocol ID
IRB2507199
Status last verified
May 2026
First submitted
30 Jan 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The dissemination plan includes sharing de-identified data for external researchers.

Publications

  • Ercoli LM, Castellon SA, Hunter AM, Kwan L, Kahn-Mills BA, Cernin PA, Leuchter AF, Ganz PA. Assessment of the feasibility of a rehabilitation intervention program for breast cancer survivors with cognitive complaints. Brain Imaging Behav. 2013 Dec;7(4):543-53. doi: 10.1007/s11682-013-9237-0.

    PubMed 23955490
  • Knotkova H, Malamud SC, Cruciani RA. Transcranial direct current stimulation (TDCS) improved cognitive outcomes in a cancer survivor with chemotherapy-induced cognitive difficulties. Brain Stimul. 2014 Sep-Oct;7(5):767-8. doi: 10.1016/j.brs.2014.05.007. Epub 2014 Jun 24. No abstract available.

    PubMed 25085269
  • Gaynor AM, Pergolizzi D, Alici Y, Ryan E, McNeal K, Ahles TA, Root JC. Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy. Brain Stimul. 2020 Jul-Aug;13(4):1108-1116. doi: 10.1016/j.brs.2020.04.013. Epub 2020 Apr 27.

    PubMed 32353419
  • Ghosh S. Improvement of gait and balance by non-invasive brain stimulation: its use in rehabilitation. Expert Rev Neurother. 2019 Feb;19(2):133-144. doi: 10.1080/14737175.2019.1564042. Epub 2019 Jan 7.

    PubMed 30601080
  • Ji Y, Ni X, Zheng K, Jiang Y, Ren C, Zhu H, Xiao M, Wang T. Synergistic effects of aerobic exercise and transcranial direct current stimulation on executive function and biomarkers in healthy young adults. Brain Res Bull. 2023 Oct 1;202:110747. doi: 10.1016/j.brainresbull.2023.110747. Epub 2023 Aug 21.

    PubMed 37611879
  • Capetti B, Conti L, Marzorati C, Grasso R, Ferrucci R, Pravettoni G. The Application of tDCS to Treat Pain and Psychocognitive Symptoms in Cancer Patients: A Scoping Review. Neural Plast. 2024 Apr 13;2024:6344925. doi: 10.1155/2024/6344925. eCollection 2024.

    PubMed 38645612
  • Artese AL, Zhou X, Tometich DB, Small BJ, Ahles TA, Ahn J, Bethea TN, Breen EC, Cohen HJ, Extermann M, Graham D, Isaacs C, Jim HSL, McDonald BC, Nakamura ZM, Patel SK, Rentscher KE, Root JC, Saykin AJ, Van Dyk K, Zhai W, Carroll JE, Mandelblatt J. Physical activity and cognition: longitudinal findings from the Thinking and Living with Cancer Study. J Natl Cancer Inst. 2024 Dec 1;116(12):2009-2021. doi: 10.1093/jnci/djae182.

    PubMed 39107910
  • Hartman SJ, Nelson SH, Myers E, Natarajan L, Sears DD, Palmer BW, Weiner LS, Parker BA, Patterson RE. Randomized controlled trial of increasing physical activity on objectively measured and self-reported cognitive functioning among breast cancer survivors: The memory & motion study. Cancer. 2018 Jan 1;124(1):192-202. doi: 10.1002/cncr.30987. Epub 2017 Sep 19.

    PubMed 28926676
  • Salerno EA, Culakova E, Kleckner AS, Heckler CE, Lin PJ, Matthews CE, Conlin A, Weiselberg L, Mitchell J, Mustian KM, Janelsins MC. Physical Activity Patterns and Relationships With Cognitive Function in Patients With Breast Cancer Before, During, and After Chemotherapy in a Prospective, Nationwide Study. J Clin Oncol. 2021 Oct 10;39(29):3283-3292. doi: 10.1200/JCO.20.03514. Epub 2021 Aug 18.

    PubMed 34406822
  • Ren X, Wang X, Sun J, Hui Z, Lei S, Wang C, Wang M. Effects of physical exercise on cognitive function of breast cancer survivors receiving chemotherapy: A systematic review of randomized controlled trials. Breast. 2022 Jun;63:113-122. doi: 10.1016/j.breast.2022.03.014. Epub 2022 Mar 28.

    PubMed 35366505
  • Lee PE, Tierney MC, Wu W, Pritchard KI, Rochon PA. Endocrine treatment-associated cognitive impairment in breast cancer survivors: evidence from published studies. Breast Cancer Res Treat. 2016 Aug;158(3):407-20. doi: 10.1007/s10549-016-3906-9. Epub 2016 Jul 18.

    PubMed 27432418
  • Kohli S, Griggs JJ, Roscoe JA, Jean-Pierre P, Bole C, Mustian KM, Hill R, Smith K, Gross H, Morrow GR. Self-reported cognitive impairment in patients with cancer. J Oncol Pract. 2007 Mar;3(2):54-9. doi: 10.1200/JOP.0722001.

    PubMed 20859374
  • Ono M, Ogilvie JM, Wilson JS, Green HJ, Chambers SK, Ownsworth T, Shum DH. A meta-analysis of cognitive impairment and decline associated with adjuvant chemotherapy in women with breast cancer. Front Oncol. 2015 Mar 10;5:59. doi: 10.3389/fonc.2015.00059. eCollection 2015.

    PubMed 25806355
  • Lindner OC, Phillips B, McCabe MG, Mayes A, Wearden A, Varese F, Talmi D. A meta-analysis of cognitive impairment following adult cancer chemotherapy. Neuropsychology. 2014 Sep;28(5):726-40. doi: 10.1037/neu0000064. Epub 2014 Mar 17.

    PubMed 24635712

Questions about this trial

What is this clinical trial studying?

A study testing Exercise + transcranial alternating current stimulation (Ex+tACS) in people with Breast Cancer, run by Florida Atlantic University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ashley L Artese, PhD (856-534-8926, aartese@fau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (time frame: From baseline to the end of the 4-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07587957, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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