Tertiary Prevention by Exercise in Colorectal Cancer Therapy (F-PROTECT)

Technical University of Munich

Status

Completed

Conditions

Colorectal Cancer

Treatments

Behavioral: Physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT01991847

F-PROTECT

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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