Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269536
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-01-17
Brief Title:
Stress-reducing Intervention in Urothelial Carcinoma
Sponsor:
Comenius University
Organization:
Comenius University
Study Overview
Official Title:
A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgm2 Cisplatin 70 mgm2 day 1 GC new course day 22 or Methotrexate 30 mgm2 day 1 Doxorubicin 30 mgm2 day 2 Vinblastine 3 mgm2 day 2 Cisplatin 70 mgm2 day 2 with Pegfilgrastim 6 mg sc day 4 ddMVAC new course day 15 in neoadjuvant setting followed by radical cystectomy or irradiation concomitantly with cisplatin 70 mgm2 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
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 mgm2 Cisplatin 70 mgm2 day 1 GC new course day 22 or Methotrexate 30 mgm2 day 1 Doxorubicin 30 mgm2 day 2 Vinblastine 3 mgm2 day 2 Cisplatin 70 mgm2 day 2 with Pegfilgrastim 6 mg sc day 4 ddMVAC new course day 15 in neoadjuvant setting followed by radical cystectomy or irradiation concomitantly with cisplatin 70 mgm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None