Clinical trial · Interventional
Stress-reducing Intervention in Urothelial Carcinoma
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
NCT06269536CI-TRIAL-00074205recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRV biofeedback | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Heart-rate variability (HRV) biofeedback intervention + standard of care
- description
- Deep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care.
- interventionNames
- Other: HRV biofeedback
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- Gemcitabine 1000 mg/m2 + Cisplatin 70 mg/m2 day 1 (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 (new course day 15) up to 4 courses followed by radical cystectomy or irradiation with cisplatin 70 mg/m2 weekly.
Primary outcomes (7)
- measure
- Primary Objective: Inflammation
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.