Exploring the Feasibility of an Exercise and Noninvasive Brain Stimulation Intervention in Breast Cancer Survivors
7 maja 2026 zaktualizowane przez: 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).
Przegląd badań
Status
Rekrutacyjny
Warunki
Szczegółowy opis
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).
Typ studiów
Interwencyjne
Zapisy (Szacowany)
40
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ashley L Artese, PhD
- Numer telefonu: 856-534-8926
- E-mail: aartese@fau.edu
Lokalizacje studiów
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-
Florida
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Boca Raton, Florida, Stany Zjednoczone, 33431
- Rekrutacyjny
- Florida Atlantic University
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Kontakt:
- Ashley L Artese, PhD
- Numer telefonu: 856-534-8926
- E-mail: aartese@fau.edu
-
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Pozorny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Adherence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sustained attention
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Body fat percentage
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
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Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
7 stycznia 2026
Zakończenie podstawowe (Szacowany)
1 stycznia 2027
Ukończenie studiów (Szacowany)
1 stycznia 2027
Daty rejestracji na studia
Pierwszy przesłany
30 stycznia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 maja 2026
Pierwszy wysłany (Rzeczywisty)
14 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
7 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby skórne
- Choroby piersi
- Zachowanie
- Choroby skóry i tkanki łącznej
- Nowotwory piersi
- Aktywność silnika
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Lecznictwo
- Dyscypliny i działania behawioralne
- Terapia stymulacji elektrycznej
- Terapia konwulsyjna
- Psychiatryczne terapie somatyczne
- Electroshock
- Techniki psychologiczne
- Ćwiczenia
- Przezczaszkowa stymulacja prądu stałego
Inne numery identyfikacyjne badania
- IRB2507199
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
The dissemination plan includes sharing de-identified data for external researchers.
Ramy czasowe udostępniania IPD
IPD will be available at the time of manuscript acceptance and publishing.
A published manuscript is planned for 2027.
Kryteria dostępu do udostępniania IPD
Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .