Bladder CancerNCT06269536
Stress-reducing Intervention in Urothelial Carcinoma
A study testing HRV biofeedback in people with Bladder Cancer, run by Comenius University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- HRV biofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Feb 2024to 15 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate liver functions.
- Basic computer skills.
- Signed informed consent.
Who cannot join
- Diabetes mellitus with symptomatic neuropathy.
- Using antiarrhythmic drugs, opiates and/or antidepressants.
- Implanted permanent pacemaker (PPM).
- Human Immunodeficiency Virus (HIV) infection.
- Not fitting inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
National Cancer Institute
Bratislava, 83310
Katarina Rejlekova, katarina.rejlekova@nou.sk
Patrik Palacka
About this study
Official title: A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
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.
Read the detailed 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.
- Conditions
- Bladder Cancer
- Being tested
- HRV biofeedback
- Keywords
- Muscle-Infiltrating Urothelial Carcinoma, Neoadjuvant Chemotherapy, Standard of Care, Heart-Rate Variability, Biofeedback Intervention, Inflammation, Quality of Life, Cognitive Functions, Salivary Cortisol Slopes, Circadian Rhythms, Sleep Quality
- Medical subject headings
- Urinary Bladder Neoplasms, Inflammation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV biofeedbackOther
Also called physiologic
Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Heart-rate variability (HRV) biofeedback intervention + standard of care | Experimental | Deep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care. Receives: Other: HRV biofeedback |
| Standard of care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 36 months
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).
Measured: 60 months
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).
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrik Palacka, Principal investigator, Faculty of Medicine, Comenius University in Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269536
- Sponsor's protocol ID
- UC-SK004
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data of HRV, cognitive functions, quality of life, inflammatory markers, salivary cortisol, sleep quality, physical activity and psychological questionnaires.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06269536
- Acronym / sponsor ID
- UC-SK004
- Conditions
- Bladder Cancer
- Keywords
- Muscle-Infiltrating Urothelial Carcinoma, Neoadjuvant Chemotherapy, Standard of Care, Heart-Rate Variability, Biofeedback Intervention, Inflammation, Quality of Life, Cognitive Functions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart-rate variability (HRV) biofeedback intervention + standard of care | Experimental | Other: HRV biofeedbackDeep 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- Diabetes mellitus with symptomatic neuropathy.
- Using antiarrhythmic drugs, opiates and/or antidepressants.
- Implanted permanent pacemaker (PPM).
- Human Immunodeficiency Virus (HIV) infection.
- Not fitting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV biofeedbackAlso: physiologicDaily deep paced breathing 3-times (minimum 7 minutes each) for 3 months | Other | Heart-rate variability (HRV) biofeedback intervention + standard of care |
Primary outcome
Primary Objective: Inflammation
Time frame: 36 months
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).
Primary Objective: Heart Rate Variability (HRV)
Time frame: 36 months
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.
Primary Objective: Quality of Life (QoL)
Time frame: 36 months
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.
Primary Objective: Working memory
Time frame: 36 months
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.
Primary objective: Executive function
Time frame: 36 months
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.
Primary objective: Salivary Cortisol Slopes
Time frame: 36 months
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).
Primary objective: Sleep Quality
Time frame: 36 months
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).
3 secondary outcomes
Secondary objective: Serious Adverse Events
Time frame: 36 months
Secondary objective: Disease-Free Survival (DFS)
Time frame: 60 months
Secondary objective: Overall Survival (OS)
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Yes. Anonymised data of HRV, cognitive functions, quality of life, inflammatory markers, salivary cortisol, sleep quality, physical activity and psychological questionnaires.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrik Palacka principal investigator
Faculty of Medicine, Comenius University in Bratislava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV biofeedback in people with Bladder Cancer, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luba Hunáková (+421290119943, luba.hunakova@fmed.uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: Inflammation (time frame: 36 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.