[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617185":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":34,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":10,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":10},{"fullName":5,"class":6},"Paracelsus Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CIPN patiients",null,"CIPN",[13],"Diagnostic Test: Questionnaire and Physical Exam",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy Controls","healthy",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Questionnaire and Physical Exam","Measurements: EORTC QLQ-CIPN 20 questionnaire, short physical performance test battery, gait and balance, 9 hole peg test, grip strength",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Florian Rieder, PhD","CONTACT","00435725553182","f.rieder@salk.at",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Florian Rieder","P.D.Dr. rer.nat.",[35],{"name":36,"class":37},"General Hospital Nuremberg & Paracelsus Medical University Nuremberg","UNKNOWN","100617185","assessing-functional-impairments-in-patients-with-chemotherapy-induced-peripheral-neuropathy-100617185",false,"NCT07315334","Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy","Assessing Functional Impairments in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)","Assess CIPN","Inclusion Criteria:\n\n\\- Male and female patients with CIPN grade ≥ 2, according to Common Terminology Criteria for Adverse Events for peripheral sensory or motor neuropathy (CTCAE) version 5\n\n\\- Age ≥ 18\n\n\\- Ongoing or completed neuropathy-inducing chemotherapy\n\n\\- Ability to stand and walk\n\n\\- Ability to fill out a questionnaire Inclusion criteria for healthy controls\n\n\\- Male and female adults (age ≥ 18)\n\n\\- Ability to stand and walk\n\n\\- Ability to fill out a questionnaire\n\nExclusion Criteria:\n\n* Pre-existing clinically manifest peripheral neuropathy prior to start of chemotherapy (e.g. caused by radiation or malignant plexopathy, lumbar or cervical radiculopathy, carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.)\n\nAcute or chronic injuries\u002F diseases of the musculoskeletal system affecting functional tests\n\n\\- Acute or chronic cardiovascular diseases affecting functional tests\n\n\\- Neurological disease affecting functional tests (for healthy controls)\n\n\\- Neurological disease other than CIPN affecting functional tests (for CIPN patients)",true,"ALL","18 Years",{"count":50,"type":51},80,"ESTIMATED","OBSERVATIONAL","Chemotherapy-induced peripheral neuropathy (CIPN) is a severe side effect of several anti-cancer agents. Typical symptoms include tingling and hypoesthesia in the fingertips and\u002For toes, which substantially impair patients' quality of life and independence. Providing effective, evidence-based treatments for CIPN remains a major challenge in clinical practice. In a recent randomized clinical trial, our group demonstrated the effectiveness of electrotherapy in reducing both sensory and motor symptoms, as assessed by the EORTC-QLQ-CIPN20 questionnaire and CIPN grading according to CTCAE. However, these findings were based exclusively on patients' subjective self-reports (EORTC QLQ CIPN 20 and C-30). To more objectively evaluate treatment success, functional assessments that capture impairments in daily activities are needed.\n\nIn this cross-sectional comparison, we will conduct comprehensive functional assessments and correlate the results with patients' subjective ratings using the EORTC-QLQ-CIPN20, QLQ-C30, and CTCAE v5.0 grading. In addition, data from matched healthy controls will be collected and compared with those of CIPN patients. The findings of this study will contribute to the development of objective measures of functional limitations caused by CIPN and provide a valuable complement to patient-reported outcome obtained through validated questionnaires.",[55],"Chemotherapy Induced Peripheral Neuropathy (CIPN)",[57],"CIPN, EORTC CIPN20, gait , balance, functional assessment, 9 hole peg test,","NOT_YET_RECRUITING","2025-12-18",{"date":61,"type":62},"2026-01-02","ACTUAL",{"date":64,"type":51},"2026-01-15",{"date":66,"type":51},"2026-12-31",{"name":5,"class":6}]