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Recruiting NCT06269536

Stress-reducing Intervention in Urothelial Carcinoma

No phase Interventional Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRV biofeedback.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma

Overview

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.

Detailed description

This is a prospective, interventional, clinical study with a target of 50 subjects and an anticipated total duration of 36 months.

The goal of this study is to test the HRV BI in patients with MIBC treated with total of 3 to 4 courses of chemotherapy Gemcitabine 1000 mg/m2 + Cisplatin 70 mg/m2 day 1 (GC, new course day 22) or Methotrexate 30 mg/m2 day 1, Doxorubicin 30 mg/m2 day 2, Vinblastine 3 mg/m2 day 2, Cisplatin 70 mg/m2 day 2 with Pegfilgrastim 6 mg s.c. day 4 (ddMVAC, new course day 15) in neoadjuvant setting followed by radical cystectomy or irradiation concomitantly with cisplatin 70 mg/m2 weekly (SOC) and compare to SOC.

Participants will undergo 4 sessions of HRV BI with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the HRV monitoring. They will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months.

Researchers will compare the effect of addition of 3-months training of HRV BI to SOC on inflammation, HRV, quality of life (QoL), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes.

Interventions

  • Other HRV biofeedback
    Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Primary outcome measures

  • Primary Objective: Inflammation [Time frame: 36 months]
  • Primary Objective: Heart Rate Variability (HRV) [Time frame: 36 months]
  • Primary Objective: Quality of Life (QoL) [Time frame: 36 months]
  • Primary Objective: Working memory [Time frame: 36 months]
  • Primary objective: Executive function [Time frame: 36 months]
  • Primary objective: Salivary Cortisol Slopes [Time frame: 36 months]
  • Primary objective: Sleep Quality [Time frame: 36 months]
Secondary outcome measures (3)
  • Secondary objective: Serious Adverse Events [Time frame: 36 months]
  • Secondary objective: Disease-Free Survival (DFS) [Time frame: 60 months]
  • Secondary objective: Overall Survival (OS) [Time frame: 60 months]

Eligibility criteria

Inclusion criteria

  • 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.
  • Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance > 60 ml/min.
  • Absolute granulocytes count 1,500/mm3 or higher, platelets 100,000/mm3 or higher, bilirubin 1.5x the upper limit of normal value and lower.
  • Adequate liver functions.
  • Basic computer skills.
  • Signed informed consent.

Exclusion criteria

  • Diabetes mellitus with symptomatic neuropathy.
  • Using antiarrhythmic drugs, opiates and/or antidepressants.
  • Implanted permanent pacemaker (PPM).
  • Human Immunodeficiency Virus (HIV) infection.
  • Not fitting inclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Slovakia · 1 center
  • National Cancer Institute — Bratislava

Identifiers

NCT: NCT06269536 · UC-SK004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗