RECRUITINGINTERVENTIONAL
Stress-reducing Intervention in Urothelial Carcinoma
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form.
Who Should NOT Join This Trial:
1. Diabetes mellitus with symptomatic neuropathy.
2. Using antiarrhythmic drugs, opiates and/or antidepressants.
3. Implanted permanent pacemaker (PPM).
4. Human weakened immune system Virus (HIV) infection.
5. Not fitting inclusion criteria.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
HRV biofeedback
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Locations (1)
National Cancer Institute
Bratislava, Slovakia