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

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ClinicalTrials.gov Identifier: NCT01210313
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Colorectal Carcinoma

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
Study Start Date : October 2010
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
no treatment


Outcome Measures

Primary Outcome Measures :
  1. feasibility of physical activity [ Time Frame: after 3 months ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry

  2. feasibility of physical activity [ Time Frame: after 6 months ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry

  3. feasibility of physical activity [ Time Frame: after 12 months ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry


Secondary Outcome Measures :
  1. increase of physical efficiency [ Time Frame: after 3 months ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry

  2. increase of physical efficiency [ Time Frame: after 6 months ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry

  3. increase of physical efficiency [ Time Frame: after 12 months ]
    evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry

  4. Quality of Life [ Time Frame: study start ]
    optional evaluation (EORTC QLQ-C30) in several trial sites

  5. Quality of Life [ Time Frame: after 3 months ]
    optional evaluation (EORTC QLQ-C30) in several trial sites

  6. Quality of Life [ Time Frame: after 6 months ]
    optional evaluation (EORTC QLQ-C30) in several trial sites

  7. Quality of Life [ Time Frame: after 9 months ]
    optional evaluation (EORTC QLQ-C30) in several trial sites

  8. Quality of Life [ Time Frame: after 12 months ]
    optional evaluation (EORTC QLQ-C30) in several trial sites

  9. vascular and metabolic effects [ Time Frame: study start ]
    10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease

  10. vascular and metabolic effects [ Time Frame: after 3 months ]
    10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease

  11. vascular and metabolic effects [ Time Frame: after 12 months ]
    10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease

  12. changes of cytokines and adiponectines [ Time Frame: study start ]
    10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease

  13. changes of cytokines and adiponectines [ Time Frame: after 3 months ]
    10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease

  14. changes of cytokines and adiponectines [ Time Frame: after 12 months ]
    10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease

  15. gen- and metabolic signs [ Time Frame: study start ]
    10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease

  16. gen- and metabolic signs [ Time Frame: after 3 months ]
    10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease

  17. gen- and metabolic signs [ Time Frame: after 12 months ]
    10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with localised colorectal carcinoma
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210313


Locations
Austria
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, Austria, 6020
District Hospital Kufstein
Kufstein, Tyrol, Austria, 6330
AKH Linz
Linz, Upper Austria, Austria, 4020
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
State Hospital Rankweil
Rankweil, Vorarlberg, Austria, 6830
Paracelsus Medical University Salzburg-Oncology, Coop. Group
Salzburg, Austria, 5020
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Investigators
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
More Information

Publications:
Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999
Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York

Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT01210313     History of Changes
Other Study ID Numbers: ABCSG C07
EXERCISE ( Other Identifier: ABCSG )
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
physical activity

Additional relevant MeSH terms:
Carcinoma
Recurrence
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases