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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01210313
First received: September 23, 2010
Last updated: March 6, 2014
Last verified: March 2014

September 23, 2010
March 6, 2014
October 2010
April 2013   (final data collection date for primary outcome measure)
  • feasibility of physical activity [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
  • feasibility of physical activity [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
  • feasibility of physical activity [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
Same as current
Complete list of historical versions of study NCT01210313 on ClinicalTrials.gov Archive Site
  • increase of physical efficiency [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
  • increase of physical efficiency [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
  • increase of physical efficiency [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
  • Quality of Life [ Time Frame: study start ] [ Designated as safety issue: No ]
    optional evaluation (EORTC QLQ-C30) in several trial sites
  • Quality of Life [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    optional evaluation (EORTC QLQ-C30) in several trial sites
  • Quality of Life [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    optional evaluation (EORTC QLQ-C30) in several trial sites
  • Quality of Life [ Time Frame: after 9 months ] [ Designated as safety issue: No ]
    optional evaluation (EORTC QLQ-C30) in several trial sites
  • Quality of Life [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    optional evaluation (EORTC QLQ-C30) in several trial sites
  • vascular and metabolic effects [ Time Frame: study start ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
  • vascular and metabolic effects [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
  • vascular and metabolic effects [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease
  • changes of cytokines and adiponectines [ Time Frame: study start ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
  • changes of cytokines and adiponectines [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
  • changes of cytokines and adiponectines [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease
  • gen- and metabolic signs [ Time Frame: study start ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
  • gen- and metabolic signs [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
  • gen- and metabolic signs [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease
Same as current
Not Provided
Not Provided
 
Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
  • feasibility of physical activity
  • increase of physical conversation
  • Quality of Life (optional)
  • vascular and metabolic effects

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

subjects with localised colorectal carcinoma

Colorectal Carcinoma
Not Provided
no treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01210313
ABCSG C07, EXERCISE
No
Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
Not Provided
Study Chair: Josef Thaler, MD Austrian Breast & Colorectal Cancer Study Group
Study Chair: Michael Fridrik, MD Austrian Breast & Colorectal Cancer Study Group
Study Chair: Alfred Fridrik, MD Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP