[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536800":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":42,"armGroups":50,"interventions":61,"overallOfficials":68,"centralContacts":73,"locations":79,"responsibleParty":98,"collaborators":42,"id":100,"slug":42,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":42,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":42,"enrollmentInfo":108,"targetDuration":42,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":82,"whyStopped":42,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Comenius University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":42},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"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\u002Fml).","36 months",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":12},"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.",{"measure":20,"description":21,"timeFrame":12},"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.",{"measure":23,"description":24,"timeFrame":12},"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.",{"measure":26,"description":27,"timeFrame":12},"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\u002Fml).",{"measure":29,"description":30,"timeFrame":12},"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).",[32,35,39],{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":38},"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",{"measure":40,"description":41,"timeFrame":38},"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).",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":48,"maskingDescription":42,"whoMasked":42},"NONE","This is a prospective, interventional, clinical study with a target of 50 subjects and an anticipated total duration of 36 months.\n\nThe 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\u002Fm2 + Cisplatin 70 mg\u002Fm2 day 1 (GC, new course day 22) or Methotrexate 30 mg\u002Fm2 day 1, Doxorubicin 30 mg\u002Fm2 day 2, Vinblastine 3 mg\u002Fm2 day 2, Cisplatin 70 mg\u002Fm2 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\u002Fm2 weekly (SOC) and compare to SOC.\n\nParticipants 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.\n\nResearchers 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.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"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.",[56],"Other: HRV biofeedback",{"label":58,"type":59,"description":60,"interventionNames":42},"Standard of care","NO_INTERVENTION","Gemcitabine 1000 mg\u002Fm2 + Cisplatin 70 mg\u002Fm2 day 1 (new course day 22) or Methotrexate 30 mg\u002Fm2 day 1, Doxorubicin 30 mg\u002Fm2 day 2, Vinblastine 3 mg\u002Fm2 day 2, Cisplatin 70 mg\u002Fm2 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\u002Fm2 weekly.",[62],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"HRV biofeedback","Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months",[52],[67],"physiologic",[69],{"name":70,"affiliation":71,"role":72},"Patrik Palacka","Faculty of Medicine, Comenius University in Bratislava","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":42,"email":78},"Luba Hunáková","CONTACT","+421290119943","luba.hunakova@fmed.uniba.sk",[80],{"facility":81,"status":82,"city":83,"state":42,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"National Cancer Institute","RECRUITING","Bratislava","83310","Slovakia","SK",{"type":88,"coordinates":89},"Point",[90,91],17.10674,48.14816,{"lat":91,"lon":90},[94,97],{"name":95,"role":76,"phone":42,"phoneExt":42,"email":96},"Katarina Rejlekova","katarina.rejlekova@nou.sk",{"name":70,"role":72,"phone":42,"phoneExt":42,"email":42},{"type":99,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100536800",false,"NCT06269536","Stress-reducing Intervention in Urothelial Carcinoma","A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma","Inclusion criteria:\n\n1. Patients older than 18 years.\n2. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.\n3. No prior chemotherapy.\n4. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.\n5. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \\> 60 ml\u002Fmin.\n6. Absolute granulocytes count 1,500\u002Fmm3 or higher, platelets 100,000\u002Fmm3 or higher, bilirubin 1.5x the upper limit of normal value and lower.\n7. Adequate liver functions.\n8. Basic computer skills.\n9. Signed informed consent.\n\nExclusion criteria:\n\n1. Diabetes mellitus with symptomatic neuropathy.\n2. Using antiarrhythmic drugs, opiates and\u002For antidepressants.\n3. Implanted permanent pacemaker (PPM).\n4. Human Immunodeficiency Virus (HIV) infection.\n5. Not fitting inclusion criteria.","ALL","18 Years",{"count":109,"type":110},50,"ESTIMATED","INTERVENTIONAL",[113],"NA","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.",[116],"Bladder Cancer",[118,119,120,121,122,123,124,125,126,127,128],"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","2024-02-13",{"date":131,"type":132},"2024-02-21","ACTUAL",{"date":134,"type":110},"2024-02-15",{"date":136,"type":110},"2029-02-15",{"name":5,"class":6},1]