[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549192":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":45,"studyPopulation":46,"armGroups":47,"interventions":53,"overallOfficials":57,"centralContacts":61,"locations":71,"responsibleParty":118,"collaborators":120,"id":127,"slug":41,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":41,"eligibilityCriteria":131,"healthyVolunteers":128,"sex":132,"minAge":133,"maxAge":41,"enrollmentInfo":134,"targetDuration":41,"studyType":137,"phases":41,"briefSummary":138,"conditions":139,"keywords":41,"overallStatus":74,"whyStopped":41,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"NFL level correlation","The primary endpoint of the study is if serum NFL\\>100 pg\u002Fml after first cycle (one cycle equals 3 weeks) of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.","Before treatment start and during four cycles (one cycle equals 3 weeks)",[14,17,20,23,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":12},"Paclitaxel exposure","To measure if high concentration of paclitaxel exposure is correlated to high NFL level in blood",{"measure":18,"description":19,"timeFrame":12},"Genes and PIPN","To measure if genetic variants in genes (e.g., CYP2C8\\*3, EPHA4\u002F5, FGD4) are associated with more server PIPN symptoms.",{"measure":21,"description":22,"timeFrame":12},"Genes and NFL","To measure if genetic variants in genes (e.g., CYP2C8\\*3, EPHA4\u002F5, FGD4) are associated with high NFL concentration in blood.",{"measure":24,"description":25,"timeFrame":12},"Genes and Paclitaxel","To measure if genetic variants in genes (e.g., CYP2C8\\*3, EPHA4\u002F5, FGD4) are associated with high paclitaxel concentration in blood.",{"measure":27,"description":28,"timeFrame":12},"Drug-drug interactions","Investigate if and which specific drug-drug interactions are correlated to developing PIPN.",{"measure":30,"description":31,"timeFrame":12},"Skin biopsies","Obtain skin biopsies from patients to elucidate which molecular mechanisms and phenotypes are associated with PIPN.",{"measure":33,"description":34,"timeFrame":12},"IENFD","Obtain skin biopsies at baseline and at the beginning of cycle 3 or 4 (one cycle equals 3 weeks) to assess if the intraepidermal nerve fiber density (IENFD) changes during paclitaxel treatment.",{"measure":36,"description":37,"timeFrame":12},"PHS","To assess whether the patients who have a sensation of heat during cooling of the skin (PHS) are also those who experience neuropathic pain.",{"measure":39,"description":40,"timeFrame":12},"Nerve fiber dysfunction","To examine if increased NFL level is correlated to changes in small and large nerve fibers dysfunction.",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","PROSPECTIVE","The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.\n\nBlood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.\n\nThe primary endpoint of the study is if serum NFL\\>100 pg\u002Fml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.","A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across four trial sites.",[48],{"label":49,"type":41,"description":50,"interventionNames":51},"Breastcancer patients","A total of 188 patients diagnosed with breast cancer who are scheduled for paclitaxel treatment, either as adjuvant or neo-adjuvant treatment, will be recruited across three trial sites.",[52],"Other: No intervention",[54],{"type":6,"name":55,"description":55,"armGroupLabels":56,"otherNames":41},"No intervention",[49],[58],{"name":59,"affiliation":5,"role":60},"Ditte Bork Iversen","STUDY_CHAIR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":41,"email":66},"Ditte Bork Iversen, MSc Pharm, PhD","CONTACT","+45 65 50 23 52","dbiversen@health.sdu.dk",{"name":68,"role":64,"phone":69,"phoneExt":41,"email":70},"Tore B. Stage, Prof","+45 65 50 36 78","tstage@health.sdu.dk",[72,90,104],{"facility":73,"status":74,"city":75,"state":41,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Odense University Hospital","RECRUITING","Odense","5000","Denmark","DK",{"type":80,"coordinates":81},"Point",[82,83],10.38831,55.39594,{"lat":83,"lon":82},[86],{"name":87,"role":64,"phone":88,"phoneExt":41,"email":89},"Marianne Vogsen","+4550932282","marianne.vogsen@rsyd.dk",{"facility":91,"status":74,"city":92,"state":41,"zip":93,"country":77,"countryCode":78,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University Hospital of Southern Denmark, Sønderborg","Sønderborg","6400",{"type":80,"coordinates":95},[96,97],9.78917,54.90896,{"lat":97,"lon":96},[100],{"name":101,"role":64,"phone":102,"phoneExt":41,"email":103},"Marianne Christensen","+4579973034","marianne.christensen.onk@rsyd.dk",{"facility":105,"status":74,"city":106,"state":41,"zip":107,"country":77,"countryCode":78,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University Hospital of Southern Denmark, Vejle","Vejle","7100",{"type":80,"coordinates":109},[110,111],9.5357,55.70927,{"lat":111,"lon":110},[114],{"name":115,"role":64,"phone":116,"phoneExt":41,"email":117},"Lise Ventzel","+4579406060","lise.ventzel@rsyd.dk",{"type":119,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[121,122,124],{"name":73,"class":6},{"name":123,"class":6},"Sygehus Lillebaelt",{"name":125,"class":126},"Sonderborg Hospital","OTHER_GOV","100549192",false,"NCT06430814","Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Age \\> 18 years\n* Willing to give informed consent\n* Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment\n* Able to speak and understand Danish\n* Diagnosed with breast cancer\n* Paclitaxel naïve patients\n\nExclusion Criteria:\n\n* Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation\n* Type 1 or 2 diabetes\n* Pregnant\n* Breastfeeding\n* Relapse of cancer diagnosis\n* Diagnosed with human immunodeficiency virus (HIV)\n* Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves).\n* Previous treatment with neurotoxic chemotherapy\n* Chronic pain from another cause\n* Metastatic cancer","FEMALE","18 Years",{"count":135,"type":136},188,"ESTIMATED","OBSERVATIONAL","Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.",[140],"Chemotherapy-induced Peripheral Neuropathy","2025-08-25",{"date":143,"type":144},"2025-09-02","ACTUAL",{"date":146,"type":144},"2024-10-10",{"date":148,"type":136},"2027-09",{"name":5,"class":6},3]