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

Обзор

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).

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).

Вмешательства

• Поведенческое 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).
• Поведенческое 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.

Первичные конечные точки

• Adherence [Срок оценки: From baseline to the end of the 4-week intervention]
• Retention [Срок оценки: From baseline to the end of the 4-week intervention]
• Acceptability [Срок оценки: From baseline to the end of the 4-week intervention]
• Safety (Adverse Events) [Срок оценки: From baseline to the end of the 4-week intervention]

Вторичные конечные точки (7)

• Sustained attention [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]
• Executive function [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]
• Inhibitory control [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]
• Working Memory [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]
• Subjective Cognition [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]
• Physical Function [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]
• Cardiorespiratory endurance [Срок оценки: Baseline, within 2 weeks following the intervention, and 4-week follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Florida Atlantic University — Boca Raton

Публикации

• 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. PMID 23955490
• 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. PMID 25085269
• 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. PMID 32353419
• 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. PMID 30601080
• 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. PMID 37611879
• 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. PMID 38645612
• 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. PMID 39107910
• 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. PMID 28926676

Идентификаторы

NCT: NCT07587957 · IRB2507199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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