Tertiary Prevention by Exercise in Colorectal Cancer Therapy

N/ACompletedNCT01991847

Technical University of Munich50 enrolled

Overview

The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

Physical activityBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Munich, Germany

Outcomes

Primary Outcomes

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.

Time frame: one year

Secondary Outcomes

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).

Time frame: at screening and 3, 6, 9, and 12 month after baseline

Peak oxygen consumption

Spiroergometry will be used to assess peak oxygen consumption (VO2peak).

Time frame: at baseline and 12 month after baseline

Patient satisfaction

Patient satisfaction will be measured using questionnaire.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.