Colorectal Cancer
Conditions
Keywords
colon, cancer, prevention, exercise, physical activity, rectal
Brief summary
The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.
Detailed description
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.
Interventions
BEHAVIORALPhysical activity
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.
Sponsors
German Cancer Aid
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* histologically confirmed nonhereditary primary Stage II or III colon cancer diagnosis or rectal cancer * written informed consent in German * histopathologically confirmed R0-resection * start of guideline conformed adjuvant chemotherapy within 12 weeks after R0-resection in Stage III colon cancer diagnosis (if necessary in Stage III colon cancer diagnosis)
Exclusion criteria
* hereditary colon cancer diagnosis * R1 and R2 resection * clinically relevant complications during recovery * secondary neoplasm * non-continuance of guideline conformed therapy * uncontrolled infection * manifest cardiac disease (e.g. unstable CAD, heart failure (NYHA IV), malignant hypertension) * clinical relevant respiratory disease (GOLD IV) * musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis) * cirrhosis of the liver (Child B and C) * Karnofsky performance status scale ≤ 60% * maximal exercise capacity ≤ 50 watt * clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin \< 8 g/dl) * physical activity level ≥ 18 MET-h/ week at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target sample size | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak oxygen consumption | at baseline and 12 month after baseline | Spiroergometry will be used to assess peak oxygen consumption (VO2peak). |
| Patient satisfaction | at 3, 6, 9, and 12 month after baseline | Patient satisfaction will be measured using questionnaire. |
| Cancer related fatigue | 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). |
| Physical activity | 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). |
| Cancer related quality of life | 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). |
| Quality of life in colorectal cancer | 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). |
| Adverse and serious adverse events | 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. |
| Anxiety and depression | 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). |
Countries
Germany
Outcome results
None listed