Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
2022年6月7日 更新者：Austrian Breast & Colorectal Cancer Study Group
- feasibility of physical activity
- increase of physical conversation
- Quality of Life (optional)
- vascular and metabolic effects
研究概览
地位
完全的
条件
详细说明
In this phase II pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation.
The study is conducted multicentric (single group) with a study population of 30 patients.
After completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks.
Planned study duration 2 years.
研究类型
观察性的
注册 (实际的)
30
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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Salzburg、奥地利、5020
- Paracelsus Medical University Salzburg-Oncology, Coop. Group
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Carinthia
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St. Veit a. d. Glan、Carinthia、奥地利、9330
- Hospital BHB St. Veit/Glan, Surgery
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Tyrol
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Innsbruck、Tyrol、奥地利、6020
- Medical University Innsbruck, Internal Medicine
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Kufstein、Tyrol、奥地利、6330
- District Hospital Kufstein
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Upper Austria
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Linz、Upper Austria、奥地利、4020
- AKH Linz
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Wels、Upper Austria、奥地利、4600
- Klinikum Wels-Grieskirchen
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Vorarlberg
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Rankweil、Vorarlberg、奥地利、6830
- State Hospital Rankweil
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
subjects with localised colorectal carcinoma
描述
Inclusion Criteria:
- complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage III or (2) stage II with risk factor
- 4-16 weeks after the end of an adjuvant chemotherapy
- ECOG 0,1
- Age > 18 years
- adequate liver-, nephro- and hemogram parameters
- physical eligibility
Exclusion Criteria:
- significant comorbidities which exclude the participation
- evidence of local recurrence or distant metastases
- non-compliance of subject
- other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ)
- clinically significant cardiovascular diseases
- treatment with beta blocker without possibility of adjustment
- left bundle-branch block
- simultaneous chemotherapy or radiotherapy
- pregnancy
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
队列和干预
团体/队列 |
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没有治疗
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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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feasibility of physical activity
大体时间：after 3 months
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evaluation by frequency and duration of training interruptions or training discontinuations
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after 3 months
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feasibility of physical activity
大体时间：after 6 months
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evaluation by frequency and duration of training interruptions or training discontinuations
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after 6 months
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feasibility of physical activity
大体时间：after 12 months
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evaluation by frequency and duration of training interruptions or training discontinuations
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after 12 months
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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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increase of physical efficiency
大体时间：after 3 months
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evaluation by exercise ergometry which will be compared with baseline exercise ergometry
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after 3 months
|
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increase of physical efficiency
大体时间：after 6 months
|
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
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after 6 months
|
|
increase of physical efficiency
大体时间：after 12 months
|
evaluation by exercise ergometry which will be compared with baseline exercise ergometry
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after 12 months
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Quality of Life scores
大体时间：study start
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optional evaluation by EORTC QLQ-C30 in several trial sites
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study start
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Quality of Life scores
大体时间：after 3 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 3 months
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Quality of Life scores
大体时间：after 6 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 6 months
|
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Quality of Life scores
大体时间：after 9 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 9 months
|
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Quality of Life scores
大体时间：after 12 months
|
optional evaluation by EORTC QLQ-C30 in several trial sites
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after 12 months
|
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vascular and metabolic effects
大体时间：study start
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10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
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study start
|
|
vascular and metabolic effects
大体时间：after 3 months
|
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
|
after 3 months
|
|
vascular and metabolic effects
大体时间：after 12 months
|
10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
|
after 12 months
|
|
changes of cytokines and adiponectines
大体时间：study start
|
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
|
study start
|
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changes of cytokines and adiponectines
大体时间：after 3 months
|
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
|
after 3 months
|
|
changes of cytokines and adiponectines
大体时间：after 12 months
|
10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
|
after 12 months
|
|
gen- and metabolic signs
大体时间：study start
|
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
|
study start
|
|
gen- and metabolic signs
大体时间：after 3 months
|
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
|
after 3 months
|
|
gen- and metabolic signs
大体时间：after 12 months
|
10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
|
after 12 months
|
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
- 学习椅：Michael Fridrik, MD、Austrian Breast & Colorectal Cancer Study Group
- 学习椅：Alfred Fridrik, MD、Austrian Breast & Colorectal Cancer Study Group
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. doi: 10.1200/JCO.2006.06.0855. Epub 2006 Jul 5.
- Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A, Schilsky RL, Fuchs CS. Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol. 2006 Aug 1;24(22):3535-41. doi: 10.1200/JCO.2006.06.0863. Epub 2006 Jul 5.
- Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
- Demark-Wahnefried W. Cancer survival: time to get moving? Data accumulate suggesting a link between physical activity and cancer survival. J Clin Oncol. 2006 Aug 1;24(22):3517-8. doi: 10.1200/JCO.2006.06.6548. Epub 2006 Jul 5. No abstract available.
- Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. doi: 10.1079/bjn19780152.
- Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999
- O'Donovan G, Owen A, Bird SR, Kearney EM, Nevill AM, Jones DW, Woolf-May K. Changes in cardiorespiratory fitness and coronary heart disease risk factors following 24 wk of moderate- or high-intensity exercise of equal energy cost. J Appl Physiol (1985). 2005 May;98(5):1619-25. doi: 10.1152/japplphysiol.01310.2004. Epub 2005 Jan 7.
- Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York
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
2010年10月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年4月1日
研究注册日期
首次提交
2010年9月23日
首先提交符合 QC 标准的
2010年9月27日
首次发布 (估计)
2010年9月28日
研究记录更新
最后更新发布 (实际的)
2022年6月9日
上次提交的符合 QC 标准的更新
2022年6月7日
最后验证
2022年6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.