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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004739
Enrollment
80
Registered
2013-03-05
Start date
2010-12-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61 G93.3

Interventions

Group 1: Antiandrogentherapy + exercise, 5 Trainingsessions per week for 6 month. 2 sessions per week are supervised (35 min on a bycycle ergometer, 70-75% of the VO2peak) Group 2: Antiandrogenthera

Sponsors

Stiftung Leben mit Krebs
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Interleukin-6, Macrophage migration inhibiting Factor (MIF), Testosterone, Insulin like growth factor 1 (IGF1) Method: ELISA Measurement time points: pre Intervention, after 3 Month, Post Intervention (after 6 months), 6 Month Post Intervention, 12 Month Post intervention

Secondary

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

Countries

Germany

Contacts

Public ContactFreerk Baumann

Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin

f.baumann@dshs-koeln.de0221 4982 4821

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 23, 2026