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

7 mei 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Ashley L Artese, PhD
  • Telefoonnummer: 856-534-8926
  • E-mail: aartese@fau.edu

Studie Locaties

  • Verenigde Staten
    • Florida
      • Boca Raton, Florida, Verenigde Staten, 33431
        • Werving
        • Florida Atlantic University
        • Contact:
          • Ashley L Artese, PhD
          • Telefoonnummer: 856-534-8926
          • E-mail: aartese@fau.edu

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Gedragsmatig: Exercise + transcranial alternating current stimulation (Ex+tACS)
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).
Sham-vergelijker: 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.
Gedragsmatig: Control
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adherence
Tijdsspanne: From baseline to the end of the 4-week intervention
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
Tijdsspanne: From baseline to the end of the 4-week intervention
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
Tijdsspanne: From baseline to the end of the 4-week intervention
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)
Tijdsspanne: From baseline to the end of the 4-week intervention
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sustained attention
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in sustained attention, measured by performance on the AX-Continuous Performance Test (AX-CPT).
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Executive function
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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).
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Inhibitory control
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in inhibitory control, measured by performance on the Flanker Compatibility Task.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Working Memory
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in working memory, measured by performance on the N-back and Backwards Counting tasks.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Subjective Cognition
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in subjective cognition, measured by the Functional Assessment Cancer Therapy-Cognition (FACT-COG)
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Physical Function
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in lower body physical function, measured by the 30-second chair stand.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Cardiorespiratory endurance
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in cardiorespiratory fitness, measured by the six-minute walk test.
Baseline, within 2 weeks following the intervention, and 4-week follow-up

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body fat percentage
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in body fat percentage measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Learning and Memory
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in learning and memory, assessed by the California Verbal Learning Test.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Quality of Life (FACT-B)
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Fatigue (FACIT-F)
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Perceived exercise benefits and barriers
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Physical Function (Short Physical Performance Battery)
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Muscle Power
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Grip strength
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in grip strength, measured using a hand-held grip strength dynamometer
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Upper body physical function
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in upper body physical function, measured by the 30-second arm curl test.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Fall Risk
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
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.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Physical Activity
Tijdsspanne: Baseline, within 2 weeks following the intervention, and 4-week follow-up
Researchers will assess pre- to post-intervention changes in physical activity, measured by an accelerometer.
Baseline, within 2 weeks following the intervention, and 4-week follow-up
Skeletal Muscle
Tijdsspanne: Baseline, within two weeks following the intervention, 4-week follow-up
Description: Researchers will assess pre- to post-intervention changes in skeletal muscle (kg) measured via bioelectrical impedance analysis using the BIA-ACC (BioTekna) device
Baseline, within two weeks following the intervention, 4-week follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Florida Atlantic University

Medewerkers

Memorial Sloan Kettering Cancer Center
Florida Department of Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 januari 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

30 januari 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB2507199

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The dissemination plan includes sharing de-identified data for external researchers.

IPD-tijdsbestek voor delen

IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for 2027.

IPD-toegangscriteria voor delen

Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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