Heart-rate variability biofeedback for bladder cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to evaluate the effectiveness of heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) undergoing neoadjuvant chemotherapy. Participants will receive standard chemotherapy treatment and will also engage in HRV BI training sessions to learn techniques for reducing stress and improving quality of life. The study will assess various outcomes, including inflammation, quality of life, cognitive functions, and treatment results over a period of 36 months. A total of 50 subjects will be enrolled to compare the effects of HRV BI alongside standard care versus standard care alone.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Patients older than 18 years.
2. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.
3. No prior chemotherapy.
4. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
5. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \> 60 ml/min.
6. 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.
7. Adequate liver functions.
8. Basic computer skills.
9. Signed informed consent.

Exclusion criteria:

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

Where it's running

• National Cancer Institute
  Bratislava, Slovakia Recruiting

Study contacts

• Principal investigator: Patrik Palacka — Faculty of Medicine, Comenius University in Bratislava
• Study coordinator: Luba Hunáková
• Email: luba.hunakova@fmed.uniba.sk
• Phone: +421290119943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.