Tests a stress-reducing breathing method for patients with bladder cancer
Tests heart-rate biofeedback training alongside standard treatment in adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: Stress-reducing Intervention in Urothelial Carcinoma
Key facts
- Where
- Bratislava, SlovakiaSee the site
Where in Slovakia
- National Cancer InstituteBratislava, SlovakiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Comenius University
- Trial code
- NCT06269536
- Record updated
- 21 February 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Using antiarrhythmic drugs, opiates and/or antidepressants; Diabetes mellitus with symptomatic neuropathy; Human Immunodeficiency Virus (HIV) infection; Implanted permanent pacemaker (PPM); Not fitting inclusion criteria.