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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT01210313
First received: September 23, 2010
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose
  • feasibility of physical activity
  • increase of physical conversation
  • Quality of Life (optional)
  • vascular and metabolic effects

Condition
Colorectal Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
no treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
ABCSG Studies - open - colorectal carcinoma  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT01210313     History of Changes
Other Study ID Numbers: ABCSG C07, EXERCISE
Study First Received: September 23, 2010
Last Updated: September 17, 2012
Health Authority: Austria: local ethics committees

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

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

ClinicalTrials.gov processed this record on May 23, 2013