A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With 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.
• 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.