Stress-reducing Intervention in Urothelial Carcinoma

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269536
• Other study ID #: UC-SK004
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: February 15, 2029

Study information

• Verified date: February 2024
• Source: Comenius University
• Contact: Luba Hunáková
• Phone: +421290119943
• Email: luba.hunakova[@]fmed.uniba.sk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 15, 2029
• Est. primary completion date: February 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell

Intervention

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

Locations

Country	Name	City	State
Slovakia	National Cancer Institute	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective: Inflammation	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 a, IL-10 in pg/ml).	36 months
Primary	Primary Objective: Heart Rate Variability (HRV)	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.	36 months
Primary	Primary Objective: Quality of Life (QoL)	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.	36 months
Primary	Primary Objective: Working memory	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.	36 months
Primary	Primary objective: Executive function	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.	36 months
Primary	Primary objective: Salivary Cortisol Slopes	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).	36 months
Primary	Primary objective: Sleep Quality	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).	36 months
Secondary	Secondary objective: Serious Adverse Events	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.	36 months
Secondary	Secondary objective: 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 disease-free survival (DFS).	60 months
Secondary	Secondary objective: Overall Survival (OS)	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).	60 months