Exploring the Feasibility of an Exercise and Noninvasive Brain Stimulation Intervention in Breast Cancer Survivors
7 мая 2026 г. обновлено: 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).
Обзор исследования
Статус
Рекрутинг
Условия
Подробное описание
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).
Тип исследования
Интервенционный
Регистрация (Оцененный)
40
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Ashley L Artese, PhD
- Номер телефона: 856-534-8926
- Электронная почта: aartese@fau.edu
Места учебы
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Florida
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Boca Raton, Florida, Соединенные Штаты, 33431
- Рекрутинг
- Florida Atlantic University
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Контакт:
- Ashley L Artese, PhD
- Номер телефона: 856-534-8926
- Электронная почта: aartese@fau.edu
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Фальшивый компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Adherence
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sustained attention
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Body fat percentage
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
7 января 2026 г.
Первичное завершение (Оцененный)
1 января 2027 г.
Завершение исследования (Оцененный)
1 января 2027 г.
Даты регистрации исследования
Первый отправленный
30 января 2026 г.
Впервые представлено, что соответствует критериям контроля качества
7 мая 2026 г.
Первый опубликованный (Действительный)
14 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Кожные заболевания
- Заболевания груди
- Поведение
- Заболевания кожи и соединительной ткани
- Новообразования молочной железы
- Двигательная активность
- Моторная активность
- Движение
- Компания скелетно -скелетно -мышечности
- Скелетно -скелетно -нейронные физиологические явления
- Терапия
- Поведенческие дисциплины и деятельность
- Электрическая стимуляционная терапия
- Судорожная терапия
- Психиатрическая соматическая терапия
- Электрошок
- Психологические методы
- Упражнение
- Транскраниальная стимуляция постоянного тока
Другие идентификационные номера исследования
- IRB2507199
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
The dissemination plan includes sharing de-identified data for external researchers.
Сроки обмена IPD
IPD will be available at the time of manuscript acceptance and publishing.
A published manuscript is planned for 2027.
Критерии совместного доступа к IPD
Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .