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临床试验/NCT05773144
NCT05773144
招募中
不适用

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

AdventHealth Translational Research Institute6 个研究点 分布在 1 个国家目标入组 219 人2023年6月1日

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.

注册库
clinicaltrials.gov
开始日期
2023年6月1日
结束日期
2027年5月1日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

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.

研究点 (6)

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