Exploring the Feasibility of an Exercise and Noninvasive Brain Stimulation Intervention in Breast Cancer Survivors
2026年5月7日 更新者：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).
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ashley L Artese, PhD
- 電話番号：856-534-8926
- メール：aartese@fau.edu
研究場所
-
-
Florida
-
Boca Raton、Florida、アメリカ、33431
- 募集
- Florida Atlantic University
-
コンタクト：
- Ashley L Artese, PhD
- 電話番号：856-534-8926
- メール：aartese@fau.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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).
|
|
偽コンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sustained attention
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body fat percentage
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月7日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年1月30日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月7日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB2507199
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The dissemination plan includes sharing de-identified data for external researchers.
IPD 共有時間枠
IPD will be available at the time of manuscript acceptance and publishing.
A published manuscript is planned for 2027.
IPD 共有アクセス基準
Any external researcher will be able to access de-identified, non, PHI, individual participant data as part of the journal's supplementary information.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。