[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510591":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":51,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"arm A - interventional","EXPERIMENTAL","Each patient in the experimental arm will wear glycerine-containing Elasto-Gel™ gloves and socks (Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA) over a disposable glove and sock liner secured by Velcro at the wrist and ankle on their hands and feet from 15 minutes before paclitaxel administration to 15 minutes after the infusion is complete (90 minutes in total).",[13],"Device: Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA",{"label":15,"type":16,"description":17,"interventionNames":18},"arm B","NO_INTERVENTION","Patients will receive planned paclitaxel chemotherapy without cryotherapy intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA","Patients in the experimental arm will wear glycerine-containing Elasto-Gel™ gloves and socks (Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA) over a disposable glove and sock liner secured by Velcro at the wrist and ankle on their hands and feet from 15 minutes before paclitaxel administration to 15 minutes after the infusion is complete (90 minutes in total).",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Maria E Lendorf, MD, PhD","CONTACT","+4526270898","maria.elisabeth.lendorf.02@regionh.dk",[32],{"facility":33,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Maria E Lendorf","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":40,"coordinates":41},"Point",[42,43],12.56553,55.67594,{"lat":43,"lon":42},[46],{"name":33,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Maria Lendorf","MD, PhD",[52,54,56,58],{"name":53,"class":6},"Danish Cancer Society",{"name":55,"class":6},"Aarhus University Hospital",{"name":57,"class":6},"Nordsjaellands Hospital",{"name":59,"class":6},"Hospital of Southern Jutland","100510591","effects-of-cryotherapy-on-taxane-induced-neuropathy-in-patients-with-breast-cancer-100510591",false,"NCT05928429","Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer","Effects of Cryotherapy on Objective and Subjective Symptoms of Taxane-Induced Neuropathy in Patients With Early Breast Cancer: A National, Multicenter, Prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\nKey inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg\u002Fm2 for one hour) 9 or 12 doses, PS 0-1\n\nExclusion Criteria:\n\nPeripheral sensory\u002Fmotor neuropathy, neuralgia or edema of the limb graded \\>=2 (CTCAE ver 5.0), Patient with Raynaud's symptoms; peripheral arterial ischemia; or any other reasons based on the primary physician's judgment.","ALL","18 Years",{"count":70,"type":71},300,"ESTIMATED","INTERVENTIONAL",[74],"NA","Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.",[77,78],"CIPN - Chemotherapy-Induced Peripheral Neuropathy","Breast Cancer","2023-06-23",{"date":81,"type":82},"2023-07-03","ACTUAL",{"date":84,"type":82},"2021-01-15",{"date":86,"type":71},"2026-11-30",{"name":49,"class":6},1]