NCT06269536

Stress-reducing Intervention in Urothelial Carcinoma

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Comenius University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
OTHER	HRV biofeedback	Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Timeline

• Start date: 2024-02-15
• Primary completion: 2027-02-15
• Completion: 2029-02-15
• First posted: 2024-02-21
• Last updated: 2024-02-21

Locations

1 site across 1 country: Slovakia