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

NCT07587957 | Recruiting

• 1 other identifier: IRB2507199
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Breast Cancer

Keywords

Breast Cancer; Cancer-related cognitive impairment; Non-invasive brain stimulation; Exercise

Outcome Measures

Primary Outcomes (4)

• 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.

  From baseline to the end of the 4-week intervention

• Retention

  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

  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)

  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 Outcomes (7)

• Sustained attention

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

• Executive function

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

• Inhibitory control

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

• Working Memory

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

• Subjective Cognition

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

Other Outcomes (12)

• Body fat percentage

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

• Learning and Memory

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

• Quality of Life (FACT-B)

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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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)

Control

SHAM COMPARATOR

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

Interventions

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).

Intervention Arm

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Atlantic University: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Florida Department of Health: collaborator

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 23955490 BACKGROUND

• 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.

  PMID: 25085269 BACKGROUND

• 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.

  PMID: 32353419 BACKGROUND

• 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.

  PMID: 30601080 BACKGROUND

• 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.

  PMID: 37611879 BACKGROUND

• 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.

  PMID: 38645612 BACKGROUND

• 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.

  PMID: 39107910 BACKGROUND

• 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.

  PMID: 28926676 BACKGROUND

• 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.

  PMID: 34406822 BACKGROUND

• 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.

  PMID: 35366505 BACKGROUND

• 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.

  PMID: 27432418 BACKGROUND

• 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.

  PMID: 20859374 BACKGROUND

• 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.

  PMID: 25806355 BACKGROUND

• 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.

  PMID: 24635712 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Ashley L Artese, PhD

CONTACT

856-534-8926; aartese@fau.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: May 14, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for 2027.
• 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.

Locations

US (1)