Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06269536

Stress-reducing Intervention in Urothelial Carcinoma

Led by Comenius University · Updated on 2024-02-21

50

Participants Needed

1

Research Sites

261 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Stress-reducing Intervention in Urothelial Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Biopsy-proven muscle-infiltrating urothelial bladder carcinoma (including variants)
  • No prior chemotherapy treatment
  • No previous malignancy except basal-cell carcinoma of the skin within last 5 years
  • Adequate kidney function with creatinine clearance over 60 ml/min
  • Absolute granulocyte count of 1,500/mm3 or higher and platelet count of 100,000/mm3 or higher
  • Bilirubin level at or below 1.5 times the upper normal limit
  • Adequate liver function
  • Basic computer skills
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Diabetes mellitus with symptomatic neuropathy
  • Use of antiarrhythmic drugs, opiates, or antidepressants
  • Implanted permanent pacemaker
  • HIV infection
  • Not meeting inclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Cancer Institute

Bratislava, Slovakia, 83310

Actively Recruiting

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Research Team

L

Luba Hunáková

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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