Stress-reducing Intervention in Urothelial Carcinoma

NCT06269536 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-21

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06269536 on ClinicalTrials.gov