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Stress-reducing Intervention in Urothelial Carcinoma - Trial NCT06269536

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.

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NCT06269536
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Trial Details
ClinicalTrials.gov โ€ข NCT06269536
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Stress-reducing Intervention in Urothelial Carcinoma
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma

Study Focus

Bladder Cancer

HRV biofeedback

Interventional

other

Sponsor & Location

Comenius University

Bratislava, Slovakia

Timeline & Enrollment

N/A

Feb 15, 2024

Feb 15, 2029

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 bladder
Malignant neoplasm: Bladder, unspecified
Malignant neoplasm: Dome of bladder
Malignant neoplasm: Overlapping lesion of bladder
Malignant neoplasm: Lateral wall of bladder

Data Source

ClinicalTrials.gov

NCT06269536

Non-Device Trial