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治験 NCT04724499 (CLARITY)（対象：乳癌、化学療法の効果、運動療法、認知変化）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。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (CLARITY)
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 NCT04724499 (CLARITY) は 介入研究 臨床試験 で、乳癌、化学療法の効果、運動療法、認知変化 に関するものです。現在は 募集中 で、2021年7月14日 から開始しています。30 名の参加者 の募集が計画されています。この治験は Dana-Farber Cancer Institute によって主催され、2026年6月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年1月27日 です。
概要
The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function.
The names of the study interventions involved in this study are/is:
- High-Intensity Interval Training (HIIT)
詳細説明
This research study is a randomized controlled pilot trial that will compare an exercise group to a control group on brain health, cardiac fitness and overall quality of life in breast cancer patients starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant)
This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer.
Participants will be randomly assigned to one of two groups:
- Group A: High Intensity Interval Training (HIIT) for 16 weeks
- Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends
The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits.
Participants will receive study treatment for 4 months and will be followed for 4 months.
The total time for participation in this study will be about 8 months.
It is expected that about 30 people will take part in this research study.
The American Institute for Cancer Research is supporting this research by providing funding for the study.
公式タイトル
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)
疾患／病気
乳癌化学療法の効果運動療法認知変化刊行物
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
- CLARITY
- 20-222
NCT番号
開始日
2021-07-14
最終更新日
2025-01-27
終了予定日
2026-06-15
目標参加者数
30
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
Breast Cancer
Chemotherapy Effect
Exercise Therapy
Cognitive Change
Chemotherapy Effect
Exercise Therapy
Cognitive Change
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
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的High-Intensity Intervals Training Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control
Participants assigned to the exercise group (HIIT), will receive an exercise bike and have 3 weekly supervised exercise training sessions for four (4) months/16weeks.
Participants can choose to participate in the exercise sessions at home via zoom or in clinic.
Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post High-Intensity Intervals Training (HIIT) tests and four (4) month follow up test and receive 3 MRIs over the span of 9 months. | High-intensity Intervals Training 16 week exercise program with stationary bike. |
実薬対照薬Attention Control Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control
Participants assigned to the Attention Control group, will receive instruction on a 16 week home-based stretching program.
Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post home-based stretching program tests and receive 3 MRIs over the span of 9 months.
At the end of the 16-week home-based stretching program, participants will be provided the option to participate in the High-Intensity Intervals Training (HIIT) program. | 注意制御 16 week stretching program. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Executive Function and Attention | Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test. | 16 weeks |
Executive Function-Global Cognition | Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment. | 16 weeks |
Executive Function-Working Memory | Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test | 16 weeks |
Executive Function-Episodic Memory | Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test | 16 weeks |
Executive Function-Semantic Fluency | Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test | 16 weeks |
Resting state connectivity and structural diffusion tensor imaging (DTI) connectivity | Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI) | 16 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Cardio Fitness-maximal aerobic capacity | Cardiorespiratory fitness will be measured through a VO2 max test | 16 weeks |
Cardio Fitness-maximal power output | Cardiorespiratory fitness will be measured through a VO2 max test | 16 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
女性
- Written informed consent prior to any study-related procedures
- Women newly diagnosed (Stage I-III) breast cancer.
- Over the age of 18 years; children under the age of 18 will be excluded due to rarity of disease
- The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Will receive (neo)adjuvant chemotherapy
- Speak English
- Able to provide physician clearance to participate in the exercise program
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Have not experienced a weight reduction ≥10% within the past 6 months
- Currently participate in less than 60 minutes of structured exercise/week
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to DFCI for assessments (54 visits total for those who elect the exercise group with on campus training session, 6 visits for those that elect the exercise at home option, 6 visits for those assigned to the control group)
- Ability to understand and the willingness to sign a written informed consent document.
- Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension or thyroid disease
- Patients with other active malignancies are ineligible for this study.
- Patients with metastatic disease
- Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
- Participates in more than 60 minutes of structured exercise/week
- Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
- Have a pacemaker or any implantable device that are not MRI safe; the BWH/DFCI Standard MRI screening form
- Is unable to travel to DFCI
- Patients who are pregnant
- Patients with claustrophobia
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Dana-Farber Cancer InstituteAmerican Institute for Cancer Research責任者
Christina Dieli-Conwright, PhD, 研究責任者, Principal Investigator, Dana-Farber Cancer Institute
試験中央連絡先
連絡先: Christina Dieli-Conwright, MD, 617-582-8321, [email protected]
連絡先: Mary Norris, MS, 857-215-0195, [email protected]
1 1カ国の場所
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
Christina Dieli-Conwright, MD, 連絡先, 617-582-8321, [email protected]
Christina Dieli-Conwright, MD, 研究責任者
募集中