Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
- Conditions
- Colorectal Carcinoma
- Interventions
- Other: Physical exercise
- Registration Number
- NCT01210313
- Lead Sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Brief Summary
* feasibility of physical activity
* increase of physical conversation
* Quality of Life (optional)
* vascular and metabolic effects
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Physical exercise Physical exercise No treatment, only physical examinations accompanying physical exercise
- Primary Outcome Measures
Name Time Method Feasibility of Physical Activity After 12 Weeks (3 Months) 3 months Evaluation of the feasibility measured in terms of training adherence during the first 12 weeks measured in actual participant-weeks in relation to the 360 planned participant-weeks during cycle 1 (week 1 to week 12)
Feasibility of Physical Activity After 26 Weeks (6 Months) 6 months Evaluation of the feasibility measured in terms of training adherence during the weeks 13 to 26 measured in actual participant-weeks in relation to the planned 420 participant-weeks during cycle 2 (week 13 to week 26)
Feasibility of Physical Activity After 52 Weeks (12 Months) 12 months Evaluation of the feasibility measured in terms of training adherence during the weeks 27 to 52 measured in actual participant-weeks in relation to the planned 780 participant-weeks during cycle 3 (week 27 to week 52)
- Secondary Outcome Measures
Name Time Method Exercise Ergometry Activity After 12 Weeks (3 Months) 3 months Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 12 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 10 METs during cycle 1 (week 1 to week 12)
Exercise Ergometry Activity After 26 Weeks (6 Months) 6 months Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 26 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 15 METs during cycle 2 (week 13 to week 26)
Exercise Ergometry Activity After 52 Weeks (12 Months) 12 months Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 52 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 18 METs during cycle 3 (week 27 to week 52)
Adiponectin at Screening Day 1 (at screening) Evaluation of adiponectin at screening as baseline for a description of changes during the study
Adiponectin After 12 Weeks (3 Months) 3 months Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study
Adiponectin After 52 Weeks (12 Months) 12 months Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study
Leptin at Screening Day 1 (at screening) Evaluation of leptin at screening as baseline for a description of changes during the study
Leptin After 12 Weeks (3 Months) 3 months Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study
Leptin After 52 Weeks (12 Months) 12 months Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study
Trial Locations
- Locations (7)
Hospital BHB St. Veit/Glan, Surgery
🇦🇹St. Veit a. d. Glan, Carinthia, Austria
Medical University Innsbruck, Internal Medicine
🇦🇹Innsbruck, Tyrol, Austria
District Hospital Kufstein
🇦🇹Kufstein, Tyrol, Austria
AKH Linz
🇦🇹Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen
🇦🇹Wels, Upper Austria, Austria
State Hospital Rankweil
🇦🇹Rankweil, Vorarlberg, Austria
Paracelsus Medical University Salzburg-Oncology, Coop. Group
🇦🇹Salzburg, Austria