Stress-reducing Intervention in Urothelial Carcinoma

Trial Title: Stress-reducing Intervention in Urothelial Carcinoma

NCT ID: NCT06269536

Condition: Bladder Cancer

Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell

Conditions: Keywords:
Muscle-Infiltrating Urothelial Carcinoma
Neoadjuvant Chemotherapy
Standard of Care
Heart-Rate Variability
Biofeedback Intervention
Inflammation
Quality of Life
Cognitive Functions
Salivary Cortisol Slopes
Circadian Rhythms
Sleep Quality

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: HRV biofeedback
Description: Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Arm group label: Heart-rate variability (HRV) biofeedback intervention + standard of care

Other name: physiologic

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Cancer Institute

Address:
City: Bratislava
Zip: 83310
Country: Slovakia

Status: Recruiting

Contact:
Last name: Katarina Rejlekova
Email: katarina.rejlekova@nou.sk

Investigator:
Last name: Patrik Palacka
Email: Principal Investigator

Start date: February 15, 2024

Completion date: February 15, 2029

Lead sponsor:
Agency: Comenius University
Agency class: Other

Source: Comenius University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06269536