Stress-reducing Intervention in Urothelial Carcinoma

Comenius University

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Other: HRV biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06269536

UC-SK004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Heart-rate variability (HRV) biofeedback intervention + standard of care

Experimental group

Description:

Deep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care.

Treatment:

Other: HRV biofeedback

Standard of care

No Intervention group

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.