NCT06269536Recruiting
Stress-reducing Intervention in Urothelial Carcinoma
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
Source: ClinicalTrials.gov · Last updated 21 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Jan 2024
- Start date
- 15 Feb 2024
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- Comenius University
- Diseases
- Bladder cancer
- NCT number
- NCT06269536
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 15 Feb 2024 to the primary completion date, 15 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Using antiarrhythmic drugs, opiates and/or antidepressants.
Other illness
- Diabetes mellitus with symptomatic neuropathy.
- Human Immunodeficiency Virus (HIV) infection.
Other
- Implanted permanent pacemaker (PPM).
- Not fitting inclusion criteria.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.