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治験 NCT06322888（対象：乳癌、女性乳癌）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
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
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 NCT06322888 は 介入研究 臨床試験 で、乳癌、女性乳癌 に関するものです。現在は 募集中 で、2024年3月28日 から開始しています。46 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12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月21日 です。
概要
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.
The names of the study groups in this study are:
- Exercise Training Group
- Waitlist Control Group
詳細説明
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. Participants will be placed into one of two study groups: Exercise Training Group vs. Waitlist Control Group. Randomization means that a participant is put into a group by chance.
The research study procedures include screening for eligibility and baseline and end of study assessments which include: breast biopsies, assessment of physical activity habits, aerobic and strength testing, blood draws and questionnaires.
Participants randomized to the exercise group will be expected to participate in exercise sessions throughout the study. They will also be asked to complete logs of their activity.
Participants will be in this research study for up to 16 weeks.
It is expected that 46 women will take part in this study.
The Breast Cancer Research Foundation is supporting this research study by providing funding.
公式タイトル
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
疾患／病気
乳癌女性乳癌その他の研究識別子
- 23-676
NCT番号
開始日
2024-03-28
最終更新日
2025-11-21
終了予定日
2026-12-31
目標参加者数
46
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
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
主目的
予防
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Arm A: Exercise Intervention Participants will be randomized and will complete:
* Baseline study visit with assessments, breast biopsy, and blood draw.
* Exercise program for 12 weeks 3x weekly and exercise logs. Additional blood draw after first exercise session.
* End of study visit with assessments, breast biopsy, and blood draw. | 運動トレーニングプログラム A 12-week aerobic and resistance-training exercise intervention with a certified exercise trainer in person or virtually. FitBit activity tracker, resistance bands, hand weights, and stationary bike will be provided to participants. Hand weights will be returned at end of study. |
非介入Arm B: Waitlist Control Participants will be randomized and will complete:
* Baseline study visit with assessments, breast biopsy, and blood draw.
* End of study visit with assessments, breast biopsy, and blood draw.
* Participants will be offered a complimentary 12-week exercise program after completing the study. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Irisin in Exercise Group | Change in circulating irisin at baseline, after 1st exercise session, and end of study in exercise group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski. | At baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks |
Change in Irisin in Control Group | Change in circulating irisin at baseline and end of study in control group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski. | At baseline and week 12, up to 16 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Tissue Markers in Exercise Group | Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Tissue Markers in Control Group | Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Exercise Group - Meso scale | Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Exercise Group - Mass cytometry | Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Control Group - Meso Scale | Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. Additionally, Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Control Group - Mass cytometry | Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Participant Weight in Exercise Group | Defined as the percent change in weight for Exercise Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Participant Weight in Control Group | Defined as the percent change in weight for Control Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Cardiorespiratory Fitness in Exercise Group | Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Cardiorespiratory Fitness in Control Group | Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
10-Repetition Max Test in Exercise Group | The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
10-Repetition Max Test in Control Group | The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Minutes of Total Exercise for Exercise Group | Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests. | Up to 16 weeks |
Change in Minutes of Total Exercise for Control Group | Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests. | Up to 16 weeks |
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
女性
健康なボランティアを受け入れる
はい
- Women aged 18-59
- Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
- Physically inactive; engaging in <60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
- Not pregnant or breastfeeding
- English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
- Written informed consent prior to any study-related procedures
- Self-reported inability to walk 2 blocks (at any pace)
- Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
- On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
- Consistent strength training in the past 3 months
- Use of weightloss drugs
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
Dana-Farber Cancer InstituteBreast Cancer Research Foundation責任者
Jennifer A. Ligibel, MD, 研究責任者, Principal Investigator, Dana-Farber Cancer Institute
試験中央連絡先
連絡先: Jennifer Ligibel, MD, 617-632-3800, [email protected]
連絡先: Anna Tanasijevic, MPH, 617-632-5584, [email protected]
2 1カ国の場所
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
実施中／登録終了
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Jennifer Ligibel, MD, 連絡先, 617-632-3800, [email protected]
Jennifer Ligibel, MD, 研究責任者
募集中