Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, 80809, Germany
NCT Number: NCT01991847
The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Munich, 80809, Germany
Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer. Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer. However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients. The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III). In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT). Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients will perform increasing volumes of moderate intensity endurance (e.g. walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months. Patients will then maintain this activity level for the remaining 9 months, with reduced supervision.
Time frame: one year
The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year.
Time frame: at screening and 3, 6, 9, and 12 month after baseline
Physical activity will be measured using physical activity diary, heart rate monitor (Sigma Sport PC 22.13), accelerometer (Aipermotion 440), and the German version of the International Physical Activity Questionnaire (IPAQ).
Time frame: at baseline and 12 month after baseline
Spiroergometry will be used to assess peak oxygen consumption (VO2peak).
Time frame: at 3, 6, 9, and 12 month after baseline
Patient satisfaction will be measured using questionnaire.
Time frame: at screening and 6 and 12 month after baseline
Fatigue will be measured using the German version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-FA13; reduced version with 13 items).
Time frame: at screening and 6 and 12 month after baseline
Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D).
Time frame: at screening and 6 and 12 month after baseline
Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30).
Time frame: at screening and 6 and 12 month after baseline
Cancer related quality of life will be assessed with the German Version of the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire in colorectal cancer (EORTC QLQ-CR29).
Time frame: one year
Adverse (e.g. dizziness, high blood pressure) and serious adverse events (e.g. death, prolonged hospitalization) will be reported within 24 hours to the study physician via form.
Technical University of Munich
Other
Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)
Acronym: F-PROTECT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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