Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

Study Overview
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Brief Summary
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feasibility of physical activity increase of physical conversation Quality of Life (optional) vascular and metabolic effects

Detailed Description
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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.

Official Title
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Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

Conditions
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Colorectal Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of physical activity | evaluation by frequency and duration of training interruptions or training discontinuations | after 3 months | 
| feasibility of physical activity | evaluation by frequency and duration of training interruptions or training discontinuations | after 6 months | 
| feasibility of physical activity | evaluation by frequency and duration of training interruptions or training discontinuations | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase of physical efficiency | evaluation by exercise ergometry which will be compared with baseline exercise ergometry | after 3 months | 
| increase of physical efficiency | evaluation by exercise ergometry which will be compared with baseline exercise ergometry | after 6 months | 
| increase of physical efficiency | evaluation by exercise ergometry which will be compared with baseline exercise ergometry | after 12 months | 
| Quality of Life scores | optional evaluation by EORTC QLQ-C30 in several trial sites | study start | 
| Quality of Life scores | optional evaluation by EORTC QLQ-C30 in several trial sites | after 3 months | 
| Quality of Life scores | optional evaluation by EORTC QLQ-C30 in several trial sites | after 6 months | 
| Quality of Life scores | optional evaluation by EORTC QLQ-C30 in several trial sites | after 9 months | 
| Quality of Life scores | optional evaluation by EORTC QLQ-C30 in several trial sites | after 12 months | 
| vascular and metabolic effects | 10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease | study start | 
| vascular and metabolic effects | 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 | 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 | 10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease | study start | 
| changes of cytokines and adiponectines | 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 | 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 | 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 | 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 | 10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease | after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity