Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Assessment of changes fat free mass |
Change from baseline in fat free mass at 16 weeks and at 6-month follow-up will be assessed using air displacement plethysmography and bioelectrical impedance analysis. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of changes in fat mass |
Change from baseline in fat mass at 16 weeks and at 6-month follow-up will be assessed using air displacement plethysmography and bioelectrical impedance analysis. From this analysis fat free mass, fat mass, body density and body water content will be derived |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of blood lipids |
Change from baseline in blood lipids at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of C-reactive protein |
Change from baseline in C-reactive protein at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of creatine kinase-myocardial band |
Change from baseline in creatine kinase-myocardial band at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of blood glucose |
Change from baseline in blood glucose at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of serum cortisol |
Change from baseline in serum cortisol at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of hemoglobin |
Change from baseline in hemoglobin at 16 weeks and at 6-month follow-up, assessed in blood serum and plasma using ELISA methods. |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of changes in quality of life |
Change from baseline in quality of life at 16 weeks and at 6-month follow-up using The European Organization for Research and Treatment of Cancer (EORTC)EORTC-QLQ30 |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of changes in fatigue |
Change from baseline in fatigue at 16 weeks and at 6-month follow-up using Multi Dimensional Fatigue Inventory (MFI) |
From baseline to the 16 week time point and from baseline to the 6-month follow-up |
|
| Other |
Assessment of physical activity, defined as minutes spent in moderate-to-vigorous intensity activity |
Assessment of physical activity, assessed by the SenseWear Armband activity monitoring device. The purpose is to monitor and to be able to adjust for the participants' physical activity outside the intervention as a possible confounder. A SenseWear Armband is worn for 7 consecutive days at three time points (baseline, 16 weeks and 6-month follow-up). |
Measurement at three time points, baseline, 16 weeks and 6-month follow-up |
|
| Other |
Adverse events |
Adverse events from training session and muscle biopsy sampling will be recorded |
Through study completion, an average of 1 year |
|
| Primary |
Assessment of changes in muscle fiber cross-sectional area |
Change from baseline in muscle fiber cross-sectional area at 16 weeks. Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers |
From baseline to the 16 week time-point |
|
| Secondary |
Assessment of changes in muscle fiber cross-sectional area |
Change from baseline in muscle fiber cross-sectional area at 6-month follow-up. Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers |
From baseline to 6-month follow-up |
|
| Secondary |
Assessment of changes in satellite cell content in muscle fiber cross-sections |
Change from baseline in satellite cell content in muscle fiber cross-sections at 16 weeks and at 6-month follow-up. Through immunohistochemical staining of muscle fiber cross-sections will satellite cell content be assessed per muscle fiber |
From baseline to the 16 week time-point and from baseline to 6-month follow-up |
|
| Secondary |
Assessment of changes in myonuclei content in muscle fiber cross-sections |
Change from baseline in myonuclei content in muscle fiber cross-sections at 16 weeks and at 6-month follow-up. Through immunohistochemical staining of muscle fiber cross-sections will myonuclei content be assessed per muscle fiber |
From baseline to the 16 week time-point and from baseline to 6-month follow-up |
|
| Secondary |
Assessment of protein levels of regulators of muscle fiber size (proteins involved in muscle protein synthesis and protein degradation (e.i. mTOR, MuRF, S6K1, p70S6k) |
Change from baseline in protein levels of regulators of muscle fiber size at 16 weeks and at 6-month follow-up. Proteins involved in regulation of muscle size (muscle protein synthesis and protein degradation) will be assessed in muscle homogenate using Western blot analysis |
From baseline to the 16 week time-point and from baseline to 6-month follow-up |
|
| Secondary |
Assessment of changes in protein levels of regulators of muscle fiber cellular stress (Heat Shock proteins: Hsp 27, aB-crystalline, Hsp 60 and Hsp 70) |
Change from baseline in protein levels of regulators of muscle fiber cellular stress at 16 weeks and at 6-month follow-up. Proteins involved in protection against cellular stress will be assessed in muscle homogenate using Western blot analysis |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Secondary |
Assessment of changes in protein levels of regulators of mitochondrial function (Citric syntase, Cox 4 and HAD) |
Change from baseline in protein levels of regulators of muscle fiber mitochondrial function at 16 weeks and at 6-month follow-up. Proteins involved in protection/enzymes involved in mitochondrial function will be assessed in muscle homogenate using Western blot analysis |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Secondary |
Assessment of changes in myokines with potential anti-tumor effects |
Change from baseline in protein levels of myokines with potential anti-tumor effects at 16 weeks and at 6-month follow-up. Myokines assossiated with potential anti-tumor effects will be assessed in muscle homogenate using Western blot analysis |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Secondary |
Changes in muscle strength |
Maximal upper- and lower extremity muscle strength will be assessed as one repetition maximum in seated chest-press and seated single-leg press |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
| Secondary |
Cardiorespiratory fitness |
Cardiorespiratory fitness will be assessed as maximal oxygen uptake during maximal walking/running until exhaustion on a treadmill |
From baseline to the 16 week time-point and from baseline to the 6-month follow-up |
|
