Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 25
- 主要终点
- Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise (Other)
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.
干预措施: Exercise (Other)
结局指标
主要结局
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
时间窗: 24 weeks
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.
次要结局
未报告次要终点