Tertiary Prevention by Exercise in Colorectal Cancer Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility Study of the PROTECT-trial (The Potential and Role Of Tertiary Prevention by Exercise in Colorectal Cancer Therapy)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>Physical activity | Behavioral: Physical activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target sample size | The primary outcome measure is to successfully recruit 50 colorectal cancer patients, and to achieve 70% compliance to regular exercise over one year. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | 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). | at screening and 3, 6, 9, and 12 month after baseline | 
| Peak oxygen consumption | Spiroergometry will be used to assess peak oxygen consumption (VO2peak). | at baseline and 12 month after baseline | 
| Patient satisfaction | Patient satisfaction will be measured using questionnaire. | at 3, 6, 9, and 12 month after baseline | 
| Cancer related fatigue | 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). | at screening and 6 and 12 month after baseline | 
| Anxiety and depression | Anxiety and depression will be assessed with the German version of the Hospital Anxiety and Depression Scale (HADS-D). | at screening and 6 and 12 month after baseline | 
| Cancer related quality of life | 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). | at screening and 6 and 12 month after baseline | 
| Quality of life in colorectal cancer | 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). | at screening and 6 and 12 month after baseline | 
| Adverse and serious adverse events | 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. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon, cancer, prevention, exercise, physical activity, rectal