Gudrun Piringer1, Michael Fridrik2, Alfred Fridrik3, Andreas Leiherer4, August Zabernigg5, Richard Greil6, Wolfgang Eisterer7, Jörg Tschmelitsch8, Alois Lang9, Sophie Frantal10, Sonja Burgstaller11, Michael Gnant12, Josef Thaler11. 1. Department of Internal Medicine IV, Klinikum Wels-Grieskirchen, Grieskirchnerstraße 42, A-4600, Wels, Austria. gudrun.piringer@hotmail.com. 2. Department of Internal Medicine III, Kepler Universitäts Klinikum, Linz, Austria. 3. Sports Medicine, Leonding, Austria. 4. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria. 5. Department of Internal Medicine, Hospital Kufstein, Kufstein, Austria. 6. Department of Internal Medicine III, Paracelsus Medical University, Salzburg, Austria. 7. Department of Internal Medicine, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria. 8. Department of Surgery, St. Veit Hospital, Sankt Veit an der Glan, Austria. 9. Department of Internal Medicine, Hospital Feldkirch, Feldkirch, Austria. 10. Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria. 11. Department of Internal Medicine IV, Klinikum Wels-Grieskirchen, Grieskirchnerstraße 42, A-4600, Wels, Austria. 12. Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Abstract
INTRODUCTION: Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. PATIENTS AND METHODS: The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. RESULTS: Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. CONCLUSION:Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.
RCT Entities:
INTRODUCTION: Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancerpatients. PATIENTS AND METHODS: The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. RESULTS: Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. CONCLUSION: Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.
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