Clinical trial NCT06269536: Stress-reducing Intervention in Urothelial Carcinoma
Official title: A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
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
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Primary Objective: Inflammation
timeFrame: 36 months
measure: Primary Objective: Heart Rate Variability (HRV)
timeFrame: 36 months
measure: Primary Objective: Quality of Life (QoL)
timeFrame: 36 months
measure: Primary Objective: Working memory
timeFrame: 36 months
measure: Primary objective: Executive function
timeFrame: 36 months
measure: Primary objective: Salivary Cortisol Slopes
timeFrame: 36 months
measure: Primary objective: Sleep Quality
timeFrame: 36 months
Secondary outcomes:
measure: Secondary objective: Serious Adverse Events
timeFrame: 36 months
measure: Secondary objective: Disease-Free Survival (DFS)
timeFrame: 60 months
measure: Secondary objective: Overall Survival (OS)
timeFrame: 60 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: National Cancer Institute
Study officials:
affiliation: Faculty of Medicine, Comenius University in Bratislava
name: Patrik Palacka
role: PRINCIPAL_INVESTIGATOR
References: