Stress-reducing Intervention in Urothelial Carcinoma
ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorComenius University
About this trial
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.
Eligibility criteria
Qualifiers
Patients older than 18 years.
Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.
No prior chemotherapy.
No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
Disqualifiers
Diabetes mellitus with symptomatic neuropathy.
Using antiarrhythmic drugs, opiates and/or antidepressants.
Implanted permanent pacemaker (PPM).
Human Immunodeficiency Virus (HIV) infection.
Trial design
Treatments tested in this trial
- HRV biofeedback
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov