C61
Conditions
Interventions
Group 1: Prospective single-arm pilot study investigating the feasibility and the effects of a structured, supervised football training program on physical and psychosocial factors in men with metasta
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of adenocarcinoma of the prostate; - Evidence of bone and/or lymph node metastases and/or locally advanced disease and/or a high-risk situation requiring radiotherapy, resulting in an indication for antiandrogen therapy; - Testosterone level = 50 ng/dL; - Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0 or 1; - Previous treatment for localized cancer, completed at least 1 year prior to study inclusion.
Exclusion criteria
Exclusion criteria: - Histology consistent with small-cell, ductal, or neuroendocrine prostate cancer; Cerebral metastases; - Visceral metastases, e.g., lung or liver metastases, as the only metastatic site; - Critical coronary artery disease; - Acute myocardial infarction or unstable angina pectoris within the past 6 months; - Uncontrolled arterial hypertension or diabetes mellitus; - Severe chronic obstructive pulmonary disease, GOLD stage III/IV; - Severe heart failure, NYHA class III/IV; - Other malignancies diagnosed within the past 5 years, except basal cell or squamous cell carcinoma of the skin or non-muscle-invasive low- to intermediate-risk urothelial carcinoma; - Physical limitations that make running and/or kicking a football impossible;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a pilot/feasibility study. The primary objective is to assess feasibility, measured by the primary endpoint of participants’ training adherence. Study feasibility is defined as a mean training adherence of at least 70% of the training sessions after completion of the intervention, i.e., after 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical parameters and secondary endpoints of the pilot study: Physical parameters: physical performance assessed by cardiopulmonary exercise testing, including relative VO2peak in ml/min/kg body weight and maximum workload in watts; body composition assessed by bioelectrical impedance analysis, including absolute and relative body fat mass, fat-free mass, and muscle mass; handgrip strength. Quality of life and mental health assessed using standardized questionnaires: EORTC QLQ-PR25, EORTC QLQ-C30, EORTC FA12, HADS, Distress Thermometer, IPAQ-SF. Cardiovascular and metabolic parameters: blood pressure and resting heart rate. Assessment time points: baseline, before the intervention; after 3 months; and after 6 months. | — |
Countries
Germany
Contacts
Public ContactMaria De Santis
Charité Universitätsmedizin Berlin
Outcome results
None listed