Tertiary Prevention by Exercise in Colorectal Cancer Therapy (F-PROTECT)
2017年11月24日 更新者：Technical University of Munich
Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
研究概览
详细说明
Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer.
Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer.
However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients.
The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III).
In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT).
Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Munich、德国、80809
- Department of Medicine, Division of Prevention and Sports Medicine TU Munich
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- histologically confirmed nonhereditary primary Stage II or III colon cancer diagnosis or rectal cancer
- written informed consent in German
- histopathologically confirmed R0-resection
- start of guideline conformed adjuvant chemotherapy within 12 weeks after R0-resection in Stage III colon cancer diagnosis (if necessary in Stage III colon cancer diagnosis)
Exclusion Criteria:
- hereditary colon cancer diagnosis
- R1 and R2 resection
- clinically relevant complications during recovery
- secondary neoplasm
- non-continuance of guideline conformed therapy
- uncontrolled infection
- manifest cardiac disease (e.g. unstable CAD, heart failure (NYHA IV), malignant hypertension)
- clinical relevant respiratory disease (GOLD IV)
- musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis)
- cirrhosis of the liver (Child B and C)
- Karnofsky performance status scale ≤ 60%
- maximal exercise capacity ≤ 50 watt
- clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin < 8 g/dl)
- physical activity level ≥ 18 MET-h/ week at screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Physical activity
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The patients will perform increasing volumes of moderate intensity endurance (e.g.
walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months.
Patients will then maintain this activity level for the remaining 9 months, with reduced supervision.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Target sample size
大体时间：one year
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The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physical activity
大体时间：at screening and 3, 6, 9, and 12 month after baseline
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Physical activity will be measured using physical activity diary, heart rate monitor (Sigma Sport PC 22.13), accelerometer (Aipermotion 440), and the German version of the International Physical Activity Questionnaire (IPAQ).
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at screening and 3, 6, 9, and 12 month after baseline
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Peak oxygen consumption
大体时间：at baseline and 12 month after baseline
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Spiroergometry will be used to assess peak oxygen consumption (VO2peak).
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at baseline and 12 month after baseline
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Patient satisfaction
大体时间：at 3, 6, 9, and 12 month after baseline
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Patient satisfaction will be measured using questionnaire.
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at 3, 6, 9, and 12 month after baseline
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Cancer related fatigue
大体时间：at screening and 6 and 12 month after baseline
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Fatigue will be measured using the German version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-FA13; reduced version with 13 items).
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at screening and 6 and 12 month after baseline
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Anxiety and depression
大体时间：at screening and 6 and 12 month after baseline
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Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).
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at screening and 6 and 12 month after baseline
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Cancer related quality of life
大体时间：at screening and 6 and 12 month after baseline
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Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30).
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at screening and 6 and 12 month after baseline
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Quality of life in colorectal cancer
大体时间：at screening and 6 and 12 month after baseline
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Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire in colorectal cancer (EORTC QLQ-CR29).
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at screening and 6 and 12 month after baseline
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Adverse and serious adverse events
大体时间：one year
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Adverse (e.g.
dizziness, high blood pressure) and serious adverse events (e.g.
death, prolonged hospitalization) will be reported within 24 hours to the study physician via form.
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one year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Martin Halle, Prof. M.D.、Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年1月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2013年11月18日
首先提交符合 QC 标准的
2013年11月18日
首次发布 (估计)
2013年11月25日
研究记录更新
最后更新发布 (实际的)
2017年11月28日
上次提交的符合 QC 标准的更新
2017年11月24日
最后验证
2017年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Physical activity的临床试验
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