Exploring the Feasibility of an Exercise and Noninvasive Brain Stimulation Intervention in Breast Cancer Survivors
7 de maio de 2026 atualizado por: 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).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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).
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ashley L Artese, PhD
- Número de telefone: 856-534-8926
- E-mail: aartese@fau.edu
Locais de estudo
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Florida
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Boca Raton, Florida, Estados Unidos, 33431
- Recrutamento
- Florida Atlantic University
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Contato:
- Ashley L Artese, PhD
- Número de telefone: 856-534-8926
- E-mail: aartese@fau.edu
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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).
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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).
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Comparador Falso: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adherence
Prazo: From baseline to the end of the 4-week intervention
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Adherence will be calculated based on the percentage of prescribed sessions attended and percentage of participants who complete the prescribed exercise and tACS sessions.
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From baseline to the end of the 4-week intervention
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Retention
Prazo: From baseline to the end of the 4-week intervention
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Retention will be determined by the number of enrolled breast cancer survivors who participate in the four-week intervention and complete post assessments.
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From baseline to the end of the 4-week intervention
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Acceptability
Prazo: From baseline to the end of the 4-week intervention
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Acceptability will be determined by the percentage of participants who report satisfaction with the intervention.
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From baseline to the end of the 4-week intervention
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Safety (Adverse Events)
Prazo: From baseline to the end of the 4-week intervention
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Safety (<5% of serious adverse events) will be determined by the percentage of participants experiencing a serious adverse event related to the program.
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From baseline to the end of the 4-week intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sustained attention
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT).
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Executive function
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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).
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Inhibitory control
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Working Memory
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Subjective Cognition
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in subjective cognition, measured by the Functional Assessment Cancer Therapy-Cognition (FACT-COG)
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Physical Function
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in lower body physical function, measured by the 30-second chair stand.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Cardiorespiratory endurance
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in cardiorespiratory fitness, measured by the six-minute walk test.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Body fat percentage
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in body fat percentage measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Learning and Memory
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in learning and memory, assessed by the California Verbal Learning Test.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Quality of Life (FACT-B)
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Fatigue (FACIT-F)
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Perceived exercise benefits and barriers
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Physical Function (Short Physical Performance Battery)
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Muscle Power
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Grip strength
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in grip strength, measured using a hand-held grip strength dynamometer
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Upper body physical function
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in upper body physical function, measured by the 30-second arm curl test.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Fall Risk
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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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.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Physical Activity
Prazo: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Researchers will assess pre- to post-intervention changes in physical activity, measured by an accelerometer.
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Baseline, within 2 weeks following the intervention, and 4-week follow-up
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Skeletal Muscle
Prazo: Baseline, within two weeks following the intervention, 4-week follow-up
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Description: Researchers will assess pre- to post-intervention changes in skeletal muscle (kg) measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device
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Baseline, within two weeks following the intervention, 4-week follow-up
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de janeiro de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2027
Conclusão do estudo (Estimado)
1 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
30 de janeiro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de maio de 2026
Primeira postagem (Real)
14 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças de pele
- Doenças da mama
- Comportamento
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias da Mama
- Atividade motora
- Atividade motora
- Movimento
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Terapêutica
- Disciplinas e atividades comportamentais
- Terapia de estimulação elétrica
- Terapia convulsiva
- Terapias somáticas psiquiátricas
- ElectroShock
- Técnicas psicológicas
- Exercício
- Estimulação de corrente direta transcraniana
Outros números de identificação do estudo
- IRB2507199
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The dissemination plan includes sharing de-identified data for external researchers.
Prazo de Compartilhamento de IPD
IPD will be available at the time of manuscript acceptance and publishing.
A published manuscript is planned for 2027.
Critérios de acesso de compartilhamento IPD
Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .