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临床试验 NCT04816006 (BRAIN) 针对乳腺癌，乳腺肿瘤，解剖分期I期乳腺癌 AJCC v8，解剖分期II期乳腺癌 AJCC v8，解剖分期IIIA期乳腺癌 AJCC v8，Cancer-related Cognitive Dysfunction目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。
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Breast Cancer, Reasoning, and Activity Intervention (BRAIN)

招募中
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临床试验NCT04816006 (BRAIN)是一项针对乳腺癌，乳腺肿瘤，解剖分期I期乳腺癌 AJCC v8，解剖分期II期乳腺癌 AJCC v8，解剖分期IIIA期乳腺癌 AJCC v8，Cancer-related Cognitive Dysfunction的干预性研究试验，目前试验状态为招募中。试验始于2024年2月22日，计划招募160名患者。该研究由妙佑医疗国际主导，预计于2027年7月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年8月1日。
简要概括
This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.
详细描述
PRIMARY OBJECTIVES:

I. Examine the effectiveness of a 6-month, community-based aerobic exercise intervention on multiple indicators of cognitive function in breast cancer survivors (BCS) aged 50 and older (N=160).

II. Gather information on the intervention's potential for scalability using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.

EXPLORATORY OBJECTIVES:

I. Explore potential moderators and mediators of the effects of aerobic exercise training on cognitive function.

II. Investigate the feasibility of urinary metabolites as biomarkers of overall diet patterns.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study.

ARM II: Patients participate in up to 9 monthly classes/webinars. Patients also receive informational portable document format (pdfs), videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.

After completion of study intervention, patients are followed up with at 6 months.

官方标题

Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training

疾病
乳腺癌乳腺肿瘤解剖分期I期乳腺癌 AJCC v8解剖分期II期乳腺癌 AJCC v8解剖分期IIIA期乳腺癌 AJCC v8Cancer-related Cognitive Dysfunction
出版物
关于此临床试验发表的科学文章和研究论文：
其他研究标识符
NCT编号
NCT04816006
实际开始日期
2024-02-22
最近更新发布
2025-08-01
预计完成日期
2027-07-31
计划入组人数
160
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
physical activity
exercise
cognition
brain health
breast cancer
主要目的
支持治疗
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Arm I (Aerobic Exercise)
Patients attend 3 weekly exercise sessions over 60-75 minutes per week in weeks 1-2, 2 sessions over 70-70 each week in weeks 3-4, 1 session over 90-120 minutes each week in weeks 5-8, biweekly sessions over 120-150 per week across weeks 9-16, and monthly sessions over at least 150 minutes per week in weeks 17-24 for a total of 20 supervised sessions. Patients undergo MRI and wear an accelerometer throughout the study.
有氧运动训练
Breast cancer survivors in the intervention group will participate in a 24-week moderate intensity exercise program led by community-based fitness center personal trainers. Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Treadmill walking is the primary mode of exercise. However, participants will be permitted to use other cardiovascular equipment (e.g., elliptical machines, stationary bicycles) as prescribed by their exercise trainer. The trainer will supervise three weekly exercise sessions in Weeks 1-2, two in Weeks 3-4, one in Weeks 5-8, biweekly across weeks 9-16, and monthly in Weeks 17-24 (N=20 supervised sessions).
阳性对照Arm II (Health Education)
Patients participate in up to 9 monthly classes/webinars. Patients also receive informational pdfs, videos, and/or podcasts, and a one-year subscription to the Mayo Clinic Health Letter. Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study.
Health Education (Active Comparator)
Breast cancer survivors in the Health Education group will participate in education sessions with a health educator and receive monthly newsletters/webinars (N=20 total contacts) across 24 weeks. The program will include cancer support and discussion of cancer-related wellness topics (e.g., stress management, coping). Control group participants will be offered a 6-month fitness center membership upon study completion.
主要终点
结果指标度量标准描述时间框架
Change in inhibitory control
Change in interference score on Stroop task, with positive values indicating greater inhibitory control.
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in cognitive flexibility
Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in executive function processing
Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in short-term memory
Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in verbal memory
Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in working memory
Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in brain volume
Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan
baseline (Month 0), post-intervention (month 6)
Change in white matter integrity
Change in fractional anisotropy as measured by diffusion MRI.
baseline (Month 0), post-intervention (month 6)
Change in resting state functional connectivity
Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence
baseline (Month 0), post-intervention (month 6)
Change in self-reported cognitive function
The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function.
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Reach
Participation rate among eligible individuals contacted about the study.
baseline (Month 0)
Adoption
Sociodemographics questionnaire to describe demographics characteristics and experience among personal trainers
post-intervention (month 6)
Change in Cardiorespiratory Fitness
Change in Peak VO2 as measured by a modified Balke treadmill graded exercise test protocol.
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in Cancer-related Fatigue
The Functional Assessment in Chronic Illness Therapy (FACIT) - Fatigue Scale will be used to measure cancer-related fatigue. Scores range from 0-52, with higher scores indicating less cancer-related fatigue.
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Implementation
Percent of session checklist items completed as intended
post-intervention (month 6)
Maintenance
The number of participants who withdraw during the follow-up period.
follow up (month 12)
Change in processing speed
Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed
baseline (Month 0), post-intervention (month 6), follow up (month 12)
Change in attention
Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention
baseline (Month 0), post-intervention (month 6), follow up (month 12)
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
50 Years
适龄性别
女性
  • PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination
  • PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination
  • PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to registration according to participant report and/or clinical determination
  • PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months
  • PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance
  • REGISTRATION: Age ≥50 years as confirmed via clinical determination
  • REGISTRATION: Able to provide medical record release to confirm eligibility
  • REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination
  • REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to pre-registration as confirmed via clinical determination
  • REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score > 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy
  • REGISTRATION: Receive physician's clearance to participate in an exercise program

NOTE: Individuals with conditions/diagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:

  • History of major multiple myocardial infarctions (MI)

  • Recent electrocardiogram (ECG) changes or recent MI

  • Resting or unstable angina

  • Significant multivessel coronary occlusion (≥ 70%) on angiography

  • Uncontrolled and/or serious arrhythmias

  • 3rd degree heart block

  • Acute congestive heart failure or ejection fraction < 30%

    • REGISTRATION: Ability to complete assessments by themselves or with assistance

  • PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease
  • PRE-REGISTRATION: Currently receiving or < 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment
  • PRE-REGISTRATION: Planned surgery during the intervention period
  • PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)
  • PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
  • PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up
  • PRE-REGISTRATION: Self-reported inability to walk without assistance or devices
  • REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination
  • REGISTRATION: Clinically significant TICS-M score (< 21) during baseline procedures
  • REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)
  • REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols
  • REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up
  • REGISTRATION: Enrolled in another physical activity program
  • REGISTRATION: Unable to walk without assistance or devices
  • REGISTRATION: Unwilling to complete study requirements
  • REGISTRATION: Unwilling to be randomized to the exercise group or health education group
  • REGISTRATION: Unable or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period
  • REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection
  • REGISTRATION: Unwilling to return to enrolling institution for follow-up
Mayo Clinic logo妙佑医疗国际868 个活跃的临床试验可供探索
研究责任方
Diane K. Ehlers, Ph.D., 主要研究者, Principal Investigator, Mayo Clinic
研究中心联系人
联系人: Melissa Cole, MS, 480-574-4052, [email protected]
联系人: Clinical Trials Referral Office, 855-776-0015, [email protected]
1 位于 1 个国家/地区的研究中心

Arizona

Mayo Clinic in Arizona, Phoenix, Arizona, 85054, United States
Melissa Cole, MS, 联系人, 480-574-4052, [email protected]
Clinical Trials Referral Office, 联系人, 855-776-0015, [email protected]
Diane K. Ehlers, Ph.D., 主要研究者
招募中