[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cipn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cipn":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100438254","chemotherapy-induced-peripheral-neurotoxicity-cipn-why-should-we-care-100438254",false,"NCT04986891","Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care","Chemotherapy Induced Peripheral Neurotoxicity (CIPN): Why Should we Care (CIPN COST) - Pilot Study","CIPN COST","Inclusion Criteria:\n\n1. Cancer patients with this characteristics:\n\n   1. at least 75 consecutive subjects sent for a neurological evaluation before 1st chemotherapy cycle (TNSc score equal to 0 which means no neuropathy);\n   2. at least 75 consecutive subjects sent for a neurological evaluation due to stable CIPN condition (CIPN defined as TNSc \\> or = 1) after chemotherapy completion (at least 2 months off treatment).\n2. Male and female subjects who are 18 years of age or older.\n3. Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.\n4. Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.\n5. Subjects must have a Karnofsky performance score greater than or equal to 70.\n\nExclusion Criteria:\n\n1. Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.\n2. Severe depression that in the opinion of the Investigator would complicate the assessments.\n3. Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g., metronidazole, isoniazid, amiodarone, antiretroviral medications).\n4. Subjects who suffer from another medical condition that can cause neuropathy (e.g., diabetes)\n5. Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","This is a pilot, observational, cross-sectional, study on socio-economic burden related to chemotherapy-induced peripheral neurotoxicity (CIPN). Investigators will collect CIPN healthcare related costs on a detailed clinical patient-level. As a sub-study, data obtained in this cross-sectional study, will be compared with administrative larger datasets on patients affected by cancer. The aim is to run a test for potential proxy variables which are available in larger administrative datasets, even if not directly measuring CIPN, to learn more about the impact of CIPN.",[25],"CIPN",[27,28,29,30,25,31],"chemotherapy","neuropathy","socio-economic indicators","neurotoxicity","quality of life","RECRUITING","2025-07-24",{"date":35,"type":36},"2025-07-29","ACTUAL",{"date":38,"type":36},"2021-07-31",{"date":40,"type":21},"2025-12",{"name":42,"class":43},"University of Milano Bicocca","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"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","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.","19 Years",{"count":53,"type":21},66,"INTERVENTIONAL",[56],"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",[25,59,60,61,62],"CIPN - Chemotherapy-Induced Peripheral Neuropathy","CIPN in Adjuvant Breast Cancer Patients","Duloxetine","Mirogabalin","NOT_YET_RECRUITING","2024-11-26",{"date":66,"type":36},"2024-12-02",{"date":68,"type":21},"2024-12-01",{"date":70,"type":21},"2025-06-30",{"name":72,"class":43},"Pusan National University Yangsan Hospital"]