Stress-reducing Intervention in Urothelial Carcinoma
NCT06269536 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-02-21
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.
Conditions
Interventions
- OTHER
-
HRV biofeedback
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Sponsors & Collaborators
-
Comenius University
lead OTHER
Principal Investigators
-
Patrik Palacka · Faculty of Medicine, Comenius University in Bratislava
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-15
- Primary Completion
- 2027-02-15
- Completion
- 2029-02-15
Countries
- Slovakia
Study Locations
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