Colorectal Carcinoma
Conditions
Keywords
physical activity
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.
Interventions
OTHERPhysical exercise
Defined exercise program
Sponsors
Austrian Breast & Colorectal Cancer Study Group
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Leptin at Screening | Day 1 (at screening) | Evaluation of leptin at screening as baseline for a description of changes during the study |
| 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 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 |
Countries
Austria
Participant flow
Recruitment details
The first participant was enrolled October 7, 2010, the last participant was enrolled March 22, 2012. Enrollment took place in 7 Austrian clinical sites. In total, 30 participants were enrolled.
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Distant recurrence | 4 |
| Overall Study | Non-compliance | 7 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 55 years |
| Cancer location Colon | 12 Participants |
| Cancer location Colon and rectum | 1 Participants |
| Cancer location Rectum | 17 Participants |
| Chemotherapy Adjuvant | 19 Participants |
| Chemotherapy Adjuvant and neoadjuvant | 11 Participants |
| Height | 175 cm |
| pM-Stage pM0 | 27 Participants |
| pM-Stage pMX | 3 Participants |
| pN-Stage pN0 | 10 Participants |
| pN-Stage pN1 | 14 Participants |
| pN-Stage pN2 | 6 Participants |
| pT-Stage pT1 | 4 Participants |
| pT-Stage pT2 | 4 Participants |
| pT-Stage pT3 | 16 Participants |
| pT-Stage pT4 | 5 Participants |
| pT-Stage pTX | 1 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
| Weight | 76 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Feasibility of Physical Activity After 12 Weeks (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)
Time frame: 3 months
Population: Total of all 30 participants enrolled
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Physical Exercise | Feasibility of Physical Activity After 12 Weeks (3 Months) | 331 Participant-weeks |
Primary
Feasibility of Physical Activity After 26 Weeks (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)
Time frame: 6 months
Population: Total of all 30 participants enrolled
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Physical Exercise | Feasibility of Physical Activity After 26 Weeks (6 Months) | 277 Participant-weeks |
Primary
Feasibility of Physical Activity After 52 Weeks (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)
Time frame: 12 months
Population: Total of all 30 participants enrolled
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Physical Exercise | Feasibility of Physical Activity After 52 Weeks (12 Months) | 468 Participant-weeks |
Secondary
Adiponectin After 12 Weeks (3 Months)
Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study
Time frame: 3 months
Population: All participants with information on adiponectin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Adiponectin After 12 Weeks (3 Months) | 8.14 μg/ml | Standard Deviation 3.79 |
Secondary
Adiponectin After 52 Weeks (12 Months)
Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study
Time frame: 12 months
Population: All participants with information on adiponectin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Adiponectin After 52 Weeks (12 Months) | 9.31 μg/ml | Standard Deviation 3.37 |
Secondary
Adiponectin at Screening
Evaluation of adiponectin at screening as baseline for a description of changes during the study
Time frame: Day 1 (at screening)
Population: All participants with information on adiponectin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Adiponectin at Screening | 9.93 μg/ml | Standard Deviation 2.88 |
Secondary
Exercise Ergometry Activity After 12 Weeks (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)
Time frame: 3 months
Population: All participants with METs information
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Exercise Ergometry Activity After 12 Weeks (3 Months) | 9.43 kcal/kg/hour | Standard Deviation 7.82 |
Secondary
Exercise Ergometry Activity After 26 Weeks (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)
Time frame: 6 months
Population: All participants with METs information
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Exercise Ergometry Activity After 26 Weeks (6 Months) | 12.7 kcal/kg/hour | Standard Deviation 7.23 |
Secondary
Exercise Ergometry Activity After 52 Weeks (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)
Time frame: 12 months
Population: All participants with METs information
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Exercise Ergometry Activity After 52 Weeks (12 Months) | 11.27 kcal/kg/hour | Standard Deviation 8.61 |
Secondary
Leptin After 12 Weeks (3 Months)
Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study
Time frame: 3 months
Population: All participants with information on leptin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Leptin After 12 Weeks (3 Months) | 41.12 ng/ml | Standard Deviation 43.07 |
Secondary
Leptin After 52 Weeks (12 Months)
Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study
Time frame: 12 months
Population: All participants with information on leptin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Leptin After 52 Weeks (12 Months) | 42.5 ng/ml | Standard Deviation 41.74 |
Secondary
Leptin at Screening
Evaluation of leptin at screening as baseline for a description of changes during the study
Time frame: Day 1 (at screening)
Population: All participants with information on leptin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Exercise | Leptin at Screening | 36.02 ng/ml | Standard Deviation 31.68 |