Effects of supervised physical activity on endurance capacity in colorectal cancer patients undergoing ambulatory Chemotherapy

Not Applicable

• Conditions: C18; Malignant neoplasm of colon

• Registration Number: DRKS00005793
• Lead Sponsor: Deutsche Sporthochschule KölnInstitut für Kreislaufforschung und SportmedizinAbt. Molekulare und Zelluläre Sportmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-11
• Study Completion: 2016-04-15
• Results First Posted: 2021-10-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

patients with curative resected colon carcinoma (UICC stadium II-III), undergoing chemotherapy for at least six months, written informed consent

Exclusion Criteria

WHO/ECOG performance status > 2,
clinical manifested heart failure (NYHA III-IV),
pulmonary partial and global insufficiency,
diability which renders usage of an bicycle ergometer,
durable thrombocytopenia < 10000/µl,
congenital or acquired thrombocytopenia or coagulation disorder,
pregnancy,
missing consent for storage and transfer of personal data according to protocol,
symtomatic Coronary disease (stress electrocardiogram recommended),
therapy refractory hypertension,
psychiatric disorder,
uncontrolled cerebral convulsion,
Psychological or medical problems which are critical in view of the responsible medical doctor

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary outcome is the physical fitness, measured by spiroergometry before and after intervention (24 weeks after baseline), and at the 3 year follow-up.

Secondary Outcome Measures

Name	Time	Method
Quality of life (EORTC QLQ-C30 and module CR-29), measurement at baseline, 12 weeks, 24 weeks and after 3 years; <br>reduction of frequency and intensity of treatment-related side effects; criteria of the National Cancer Institute (NCI-CTC);<br>improvement of event-free survival,<br>investigation of possible molecular mechanisms of physical activity: <br>radical formation via reactive oxygene/nitrogene species (ROS / RNS), hormone status: insulin, IGF1 und IGFBP, FACS analysis for immune status, cytokine profiles: INFgamma, TNFalpha, TGFbeta, IL-1/6, MF, IL-8, flexibility of erythrocytes;<br>blood samples will be taken at baseline, after 24 weeks and after 3 year follow up<br>