ProImmun Study- Influence of an endurance exercise program on the immune function and quality of life of prostate cancer patients undergoing Antiandrogen- or Chemotherapy

Not Applicable

Recruiting

• Conditions: C61; G93.3; Malignant neoplasm of prostate; Postviral fatigue syndrome

• Registration Number: DRKS00004739
• Lead Sponsor: Stiftung Leben mit Krebs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

•Patients with advanced prostate cancer receiving Antiandrogen therapy for at least 4 weeks or
•Patients with advanced prostate cancer receiving Antiandrogen therapy in combination with chemotherapy (baseline test before chemotherapy)
•Hemoglobin > 9g/dl
•Ejection fraction > 60%
•forced expiratory volume in one second > 50%
•Age > 18 years
•Expectation of life > 6 month
•Written consent
•Inconspicuous ultrasound of the patients heart
•Inconspicuous ECG (rest and stress)

Exclusion Criteria

•Anemia < 8g/dl
•Platelet count < 10000/µl
•COPD
•CNS Metastasis
•Epilepsy
•Planned Surgery
•Heart failure (NYHA III-IV)
•Coronary disease
•Therapy refractory Hypertension
•Other internistic diseases that unable patients to exercise
•Orthopedic handicaps that unable patients to exercise
•Psychological 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
Interleukin-6, Macrophage migration inhibiting Factor (MIF), Testosterone, Insulin like growth factor 1 (IGF1)<br><br>Method: ELISA<br><br>Measurement time points: pre Intervention, after 3 Month, Post Intervention (after 6 months), 6 Month Post Intervention, 12 Month Post intervention

Secondary Outcome Measures

Name	Time	Method
Immunstatus > FACS-Analyse (fluorescence activated cell sorting)<br><br>Oxidative Stress > FORT (free oxygen radicals test)<br><br>Antioxidative Capacity > FORD (Free Oxygen Radicals Defence)<br><br>Fatigue > Questionaire (MFI-20) (Multidimensional Fatigue Inventory)<br><br>Edurance capacity (VO2peak) > Spiroergometry<br><br>Activity level > Questionaire (Freiburger Fragebogen zur körperlichen Aktivität)<br><br>Quality of life > Questionaires (EORTC QLQ-C30+ PR25)<br><br>Measure timepoints: See primary outcome<br>