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NCT06269536Recruiting

Stress-reducing Intervention in Urothelial Carcinoma

A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
Comenius UniversityClinicalTrials.govother
Study focus
Disease/Condition
Bladder Cancer
Drug/Device/Intervention
HRV biofeedback
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Comenius University
Location
Bratislava, Slovakia
Timeline & enrollment
Phase
N/A
Start date
Feb 15, 2024
End date
Feb 15, 2029
Enrollment
50 participants
Primary outcome

Primary Objective: Inflammation,Primary Objective: Heart Rate Variability (HRV),Primary Objective: Quality of Life (QoL),Primary Objective: Working memory,Primary objective: Executive function,Primary objective: Salivary Cortisol Slopes,Primary objective: Sleep Quality

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.

ICD-10 classifications
Malignant neoplasm of bladderMalignant neoplasm: Bladder, unspecifiedMalignant neoplasm: Dome of bladderMalignant neoplasm: Overlapping lesion of bladderMalignant neoplasm: Lateral wall of bladder
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06269536
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06269536 through Pure Global AI's free database. This phase not specified trial is sponsored by Comenius University and is currently Recruiting. The study focuses on Bladder Cancer. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.