Stress-reducing Intervention in Urothelial Carcinoma
The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone.
- EligibilityCriteria: Inclusion criteria:  Patients older than 18 years. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy. No prior chemotherapy. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance > 60 ml/min. Absolute granulocytes count 1,500/mm3 or higher, platelets 100,000/mm3 or higher, bilirubin 1.5x the upper limit of normal value and lower. Adequate liver functions. Basic computer skills. Signed informed consent.  Exclusion criteria:  Diabetes mellitus with symptomatic neuropathy. Using antiarrhythmic drugs, opiates and/or antidepressants. Implanted permanent pacemaker (PPM). Human Immunodeficiency Virus (HIV) infection. Not fitting inclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult