RecruitingNot ApplicableNCT06269536
Stress-reducing Intervention in Urothelial Carcinoma
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
Sponsor
Comenius University
Enrollment
50 participants
Start Date
Feb 15, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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 Criteria4
- Diabetes mellitus with symptomatic neuropathy.
- Using antiarrhythmic drugs, opiates and/or antidepressants.
- Implanted permanent pacemaker (PPM).
- Human Immunodeficiency Virus (HIV) infection.
Interventions
OTHERHRV biofeedback
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06269536
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