Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Rare Diseases

Inflammation

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Gemcitabine

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Doxorubicin

Liposomal doxorubicin

Methotrexate

Cisplatin

Vinblastine

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

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.

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

HRV biofeedback

Luba Hunáková

Katarina Rejlekova

Patrik Palacka

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.

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.

Stress-reducing Intervention in Urothelial Carcinoma

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

Anonymised data of HRV, cognitive functions, quality of life, inflammatory markers, salivary cortisol, sleep quality, physical activity and psychological questionnaires.

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on inflammation (IL-6, Tumor necrosis factor α, IL-10 in pg/ml).

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on HRV indexed by the root mean square of successive differences between heartbeats (RMSSD) in ms.

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on EORTC-QLQ-C30 (version 3) score. The EORTC-QLQ-C30 has 30 items divided into five functional scales (physical, role, cognitive, emotional, and social), and three symptom scales (fatigue, pain, and nausea and vomiting). The score for each scale as well as the sum score for the whole instrument is standardized to values 0 to 100, with a higher score meaning a worse outcome.

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on working memory measured by digit span test score (the number of remembered digits in the longest passed sequence), for both forward and backward condition.

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on executive function measured by Stroop task mean response time for color-word condition.

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on salivary cortisol slopes (difference between bedtime and awakening saliva cortisol concentration in ng/ml).

The effect of 3-month heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on sleep quality measured by both actigraphy and self-report data. The main variables are total time spent sleeping (in hours and minutes), and sleep efficiency (proportion of time spent sleeping vs. time spent in bed trying to sleep).

The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on serious adverse events (SAEs) of chemotherapy.

The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on disease-free survival (DFS).

The effect of 3-months heart rate variability (HRV) biofeedback training and conventional cancer treatment (standard of care, SOC) vs. SOC alone on overall survival (OS).

Comenius University

Fatigue

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Renal Cell Carcinoma

Angiogenesis Inhibitors

Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic

Florence JOLY-LOBBEDEZ, PD

Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer

Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study

Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer.

Studying the different parameters of quality of life and their evolution over time.

Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue.

Search for biological disturbances may be related to fatigue and cognitive disorders.

Assessing the impact of anxiety and depression at the waning of treatment

Compare the list of symptoms considered important by the patient compared to those recorded in the medical record.

sess the impact on the sexuality of patients with the waning of treatment

Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stress-reducing Intervention in Urothelial Carcinoma	NCT06269536	Bladder Cancer	HRV biofeedback	18 Years -	Comenius University
Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer	NCT01336231	Metastatic Kidn...		18 Years -	Centre Francois Baclesse
Stress-reducing Intervention in Urothelial Carcinoma	NCT06269536	Bladder Cancer	HRV biofeedback	18 Years -	Comenius University

Spots Global Cancer Trial Database for cognitive functions