Stress-reducing Intervention in Urothelial Carcinoma
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2024
CompletedStudy Start
First participant enrolled
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2029
February 21, 2024
February 1, 2024
3 years
January 17, 2024
February 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 α, IL-10 in pg/ml).
36 months
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 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 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 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 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 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 Outcomes (3)
Secondary objective: Serious Adverse Events
36 months
Secondary objective: Disease-Free Survival (DFS)
60 months
Secondary objective: Overall Survival (OS)
60 months
Study Arms (2)
Heart-rate variability (HRV) biofeedback intervention + standard of care
EXPERIMENTALDeep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care.
Standard of care
NO INTERVENTIONGemcitabine 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.
Interventions
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Diabetes mellitus with symptomatic neuropathy.
- Using antiarrhythmic drugs, opiates and/or antidepressants.
- Implanted permanent pacemaker (PPM).
- Human Immunodeficiency Virus (HIV) infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Institute
Bratislava, 83310, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrik Palacka
Faculty of Medicine, Comenius University in Bratislava
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2024
First Posted
February 21, 2024
Study Start
February 15, 2024
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
February 15, 2029
Last Updated
February 21, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will became available together with the publication and will be available for 5 years.
- Access Criteria
- Open.
Anonymised data of HRV, cognitive functions, quality of life, inflammatory markers, salivary cortisol, sleep quality, physical activity and psychological questionnaires.