Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
概览
- 阶段
- 不适用
- 干预措施
- Aerobic exercise
- 疾病 / 适应症
- Colonic Neoplasms
- 发起方
- AdventHealth Translational Research Institute
- 入组人数
- 219
- 试验地点
- 6
- 主要终点
- Chemotherapy Relative Dose Intensity
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.
研究者
Justin Brown
Senior Investigator
AdventHealth Translational Research Institute
入排标准
入选标准
- •Age ≥18 years
- •Histologically confirmed stage II or III colon cancer
- •Completed surgical resection with curative intent
- •Plan to initiate chemotherapy
- •Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise
- •No planned major surgery during the study period
- •Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
- •Can walk 400 meters
- •Can read and speak English
- •Ability to provide written informed consent
排除标准
- •Evidence of metastatic colon cancer
- •Concurrently actively treated other (non-colon) cancer
- •Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
- •Currently participating in another study with competing outcomes
- •Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol
- •Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
研究组 & 干预措施
225 min/wk aerobic exercise
Aerobic exercise at a dose of 225 minutes per week
干预措施: Aerobic exercise
Attention control
Static stretching
干预措施: Progressive stretching
75 min/wk aerobic exercise
Aerobic exercise at a dose of 75 minutes per week
干预措施: Aerobic exercise
150 min/wk aerobic exercise
Aerobic exercise at a dose of 150 minutes per week
干预措施: Aerobic exercise
300 min/wk aerobic exercise
Aerobic exercise at a dose of 300 minutes per week
干预措施: Aerobic exercise
结局指标
主要结局
Chemotherapy Relative Dose Intensity
时间窗: 12- or 24-weeks
The ratio of the delivered dose intensity to the standard or planned dose intensity.