Идёт набор NCT06269536

Stress-reducing Intervention in Urothelial Carcinoma

Без фазы С лечением Bladder Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: HRV biofeedback.
Кому может быть актуально: Состояния в реестре: Bladder Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Словакия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Другое HRV biofeedback
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months

Первичные конечные точки

Primary Objective: Inflammation [Срок оценки: 36 months]
Primary Objective: Heart Rate Variability (HRV) [Срок оценки: 36 months]
Primary Objective: Quality of Life (QoL) [Срок оценки: 36 months]
Primary Objective: Working memory [Срок оценки: 36 months]
Primary objective: Executive function [Срок оценки: 36 months]
Primary objective: Salivary Cortisol Slopes [Срок оценки: 36 months]
Primary objective: Sleep Quality [Срок оценки: 36 months]

Вторичные конечные точки (3)

Secondary objective: Serious Adverse Events [Срок оценки: 36 months]
Secondary objective: Disease-Free Survival (DFS) [Срок оценки: 60 months]
Secondary objective: Overall Survival (OS) [Срок оценки: 60 months]

Критерии участия

Критерии включения

Patients older than 18 years.
Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.
No prior chemotherapy.
No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.
Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance > 60 ml/min.
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.
Adequate liver functions.
Basic computer skills.
Signed informed consent.