[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570802":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Pusan National University Yangsan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mirogabalin Group","EXPERIMENTAL",null,[13],"Drug: Duloxetine",{"label":15,"type":16,"description":11,"interventionNames":17},"Duloxetine Group","ACTIVE_COMPARATOR",[18],"Drug: Mirogabalin",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Mirogabalin","Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Duloxetine","Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Seung-mi Yeo","CONTACT","010-3171-9583","seungmi7@gmail.com",[36],{"facility":37,"status":11,"city":38,"state":11,"zip":39,"country":40,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":41},"Yangsan Pusan National University Hospital","Mulgeum","50612","South Korea",[42],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100570802","comparison-of-the-efficacy-and-safety-of-mirogabalin-and-duloxetine-in-chemotherapy-induced-peripheral-neuropathy-in-a-randomized-controlled-trial-a-quality-of-life-study-in-cancer-survivors-100570802",false,"NCT06711978","Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors","Inclusion Criteria:\n\n* Cancer survivors aged 19 years or older.\n* Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).\n* Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.\n* Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]) is permitted if the following conditions are met:\n\n  1. No new analgesics are introduced.\n  2. Current analgesics are not discontinued.\n  3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.\n* Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)\n* Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.\n* Pregnant or breastfeeding patients.\n* Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.\n* Patients with renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin) or hepatic dysfunction.\n* Patients with planned surgical procedures within 4 weeks of enrollment.","ALL","19 Years",{"count":54,"type":55},66,"ESTIMATED","INTERVENTIONAL",[58],"NA","To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).\n\nThere will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).\n\nParticipants will:\n\n* Take drug duloxetine or a mirogabalin every day for 4 weeks.\n* Visit the clinic once every 2 weeks for checkups and tests",[61,62,63,26,22],"CIPN","CIPN - Chemotherapy-Induced Peripheral Neuropathy","CIPN in Adjuvant Breast Cancer Patients","NOT_YET_RECRUITING","2024-11-26",{"date":67,"type":68},"2024-12-02","ACTUAL",{"date":70,"type":55},"2024-12-01",{"date":72,"type":55},"2025-06-30",{"name":5,"class":6},1]