Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
18 Years
N/A
Both
Colorectal Carcinoma
Trial Information
Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
feasibility of physical activity
Outcome Description:
evaluation due to exercise ergometry which will be compared at the different measure points with primary exercise ergometry
Outcome Time Frame:
after 3 months
Safety Issue:
No
Principal Investigator
Josef Thaler, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Austrian Breast & Colorectal Cancer Study Group
Authority:
Austria: local ethics committees
Study ID:
ABCSG C07
NCT ID:
NCT01210313
Start Date:
October 2010
Completion Date:
January 2014
Related Keywords:
- Colorectal Carcinoma
- physical activity
- Carcinoma
- Colorectal Neoplasms
- Recurrence
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