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治験 NCT04816006 (BRAIN)（対象：乳癌、乳腺腫瘍、解剖学的ステージI乳がんAJCC v8、解剖学的ステージII乳がんAJCC v8、解剖学的ステージIIIA乳がんAJCC v8、Cancer-related Cognitive Dysfunction）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Breast Cancer, Reasoning, and Activity Intervention (BRAIN)

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04816006 (BRAIN) は 介入研究 臨床試験 で、乳癌、乳腺腫瘍、解剖学的ステージI乳がんAJCC v8、解剖学的ステージII乳がんAJCC v8、解剖学的ステージIIIA乳がんAJCC v8、Cancer-related Cognitive Dysfunction に関するものです。現在は 募集中 で、2024年2月22日 から開始しています。160 名の参加者 の募集が計画されています。この治験は メイヨー・クリニック によって主催され、2027年7月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月1日 です。
概要
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.
詳細説明
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.

公式タイトル

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

疾患／病気
乳癌乳腺腫瘍解剖学的ステージI乳がんAJCC v8解剖学的ステージII乳がんAJCC v8解剖学的ステージIIIA乳がんAJCC v8Cancer-related Cognitive Dysfunction
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
NCT番号
NCT04816006
開始日
2024-02-22
最終更新日
2025-08-01
終了予定日
2027-07-31
目標参加者数
160
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
physical activity
exercise
cognition
brain health
breast cancer
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的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.
有酸素運動トレーニング
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).
実薬対照薬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.
主要評価項目
評価指標指標の説明時間枠
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)
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
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メイヨー・クリニック869 件のアクティブな治験を探索
National Cancer Institute (NCI) logoアメリカ国立がん研究所3030 件のアクティブな治験を探索
責任者
Diane K. Ehlers, Ph.D., 研究責任者, Principal Investigator, Mayo Clinic
試験中央連絡先
連絡先: Melissa Cole, MS, 480-574-4052, [email protected]
連絡先: Clinical Trials Referral Office, 855-776-0015, [email protected]
1 1カ国の場所

Arizona

Mayo Clinic in Arizona, Phoenix, Arizona, 85054, United States
Melissa Cole, MS, 連絡先, 480-574-4052, [email protected]
Clinical Trials Referral Office, 連絡先, 855-776-0015, [email protected]
Diane K. Ehlers, Ph.D., 研究責任者
募集中