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临床试验 NCT04589468 针对乳腺癌，前列腺癌，结直肠癌，I期乳腺癌，II期乳腺癌，III 期乳腺癌，I期前列腺癌，II期前列腺癌，III期前列腺癌，I期结直肠癌，II期结直肠癌，III期结直肠癌目前进行中但不再招募。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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纪念斯隆-凯特琳癌症中心Researching the Effect of Exercise on Cancer
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临床试验NCT04589468是一项针对乳腺癌，前列腺癌，结直肠癌，I期乳腺癌，II期乳腺癌，III 期乳腺癌，I期前列腺癌，II期前列腺癌，III期前列腺癌，I期结直肠癌，II期结直肠癌，III期结直肠癌的干预性研究试验，目前试验状态为进行中但不再招募。试验始于2020年10月2日，计划招募33名患者。该研究由纪念斯隆-凯特琳癌症中心主导，预计于2026年10月2日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月5日。
简要概括
Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.
官方标题
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
疾病
乳腺癌前列腺癌结直肠癌I期乳腺癌II期乳腺癌III 期乳腺癌I期前列腺癌II期前列腺癌III期前列腺癌I期结直肠癌II期结直肠癌III期结直肠癌其他研究标识符
- 20-378
NCT编号
实际开始日期
2020-10-02
最近更新发布
2025-11-05
预计完成日期
2026-10-02
计划入组人数
33
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中但不再招募
关键词
Breast Cancer
Prostate Cancer
Colorectal Cancer
exercise
ctDNA
20-378
Memorial Sloan Kettering Cancer Center
Prostate Cancer
Colorectal Cancer
exercise
ctDNA
20-378
Memorial Sloan Kettering Cancer Center
主要目的
预防
分配方式
非随机
干预模型
序贯设计
盲法
无（开放性试验）
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Dose-Finding/Escalation Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial. | 锻炼 Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial. |
实验性Dose Expansion An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D. | 锻炼 Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b. | Using an adaptive phase 1 (non-randomized) design, non-exercising (i.e., \<60 mins/wk of moderate or vigorous exercise) post-treatment patients with primary breast, prostate, or colorectal cancer and detectable ctDNA (n=50) will be administered one of five escalating dose levels. | 24 weeks |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following:
° High-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for Phase 1a)
Stage 3 or
ctDNA positive
° High-risk breast cancer
Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),
Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,
CPS-EG score ≥ 3,
CPS-EG score ≥2 w ith ypN+, or
Recurrence score ≥ 25
No evidence of disease
Age ≥ 18
Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy
Non-exercising (i.e., < 30 minutes of moderate and < 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry)
° If ≥ 30 minutes but less than 45 minutes of moderate exercise/week, or if ≥ 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the PI.
Cleared for exercise participation as per screening clearance via PAR-Q+
Willingness to comply with all study-related procedures
- Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
- Any other current diagnosis of invasive cancer of any kind
- Distant metastatic malignancy of any kind
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
纪念斯隆-凯特琳癌症中心737 个活跃的临床试验可供探索没有联系数据。
8 位于 1 个国家/地区的研究中心
California
Natera, Inc. (Data or Specimen Analysis Only), San Carlos, California, 94070, United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States
New York
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States