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Stress-reducing Intervention in Urothelial Carcinoma

RecruitingNAAges 18 Years - anyAllComenius University
NCT06269536 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion criteria: 1. Patients older than 18 years. 2. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy. 3. No prior chemotherapy. 4. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. 5. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min. 6. 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. 7. Adequate liver functions. 8. Basic computer skills. 9. Signed informed consent. Exclusion criteria: 1. Diabetes mellitus with symptomatic neuropathy. 2. Using antiarrhythmic drugs, opiates and/or antidepressants. 3. Implanted permanent pacemaker (PPM). 4. Human Immunodeficiency Virus (HIV) infection. 5. Not fitting inclusion criteria.
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What it tests

  • HRV biofeedback
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Where

1 site
National Cancer Institute
Bratislava, Slovakia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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