[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605625":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":18,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":18,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Compression Stocking Arm","EXPERIMENTAL","Each participant will wear a medical-grade compression stocking (Class II, 20-30 mmHg) on the assigned foot throughout the entire treatment period with antibody-drug conjugates (ADCs). Stockings are worn daily except during bathing.",[13],"Device: Medical-grade compression stocking",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm (No Stocking)","NO_INTERVENTION","The contralateral foot will not receive any compression stocking and will be observed under the same ADC treatment conditions. Each participant serves as their own control.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Medical-grade compression stocking","A knee-high compression stocking providing 20-30 mmHg pressure will be applied to the assigned foot during the ADC treatment period to prevent chemotherapy-induced peripheral neuropathy (CIPN). Stockings will be worn daily, except during bathing.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Sheng Zhang, PhD","CONTACT","86+18017317442","568841700@qq.com",[32],{"facility":33,"status":34,"city":35,"state":18,"zip":18,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":47,"phoneExt":18,"email":48},"Dr. Wan","08602164175590","wanofficial@foxmail.com",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Sheng Zhang","Prof.","100605625","compression-stockings-to-prevent-peripheral-neuropathy-caused-by-antibody-drug-conjugates-in-urothelial-carcinoma-patients-100605625",false,"NCT07164950","Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients","A Multicenter, Prospective, Phase II Clinical Trial Investigating the Use of Compression Stockings to Prevent Peripheral Neuropathy Induced by Antibody-Drug Conjugates (ADCs) in Patients With Urothelial Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years Histologically or cytologically confirmed advanced malignancy (including but not limited to urothelial carcinoma) eligible for MMAE-containing ADC therapy (e.g., EV, DV, BV)\n* ECOG performance status 0-2\n* No baseline peripheral neuropathy ≥ Grade 1 (CTCAE v5.0)\n* Stable tumor status without other neurotoxic drugs in the past 2 months\n* Adequate organ function (blood counts, liver and kidney function) per protocol\n* Expected survival ≥ 3 months\n* Ability and willingness to comply with study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Poor compliance or inability to follow protocol\n* Pre-existing peripheral neuropathy ≥ Grade 1 from prior platinum\u002Ftaxane treatment\n* Severe diabetes or peripheral vascular disease\n* Neurological disorders causing nerve compression (e.g., carpal tunnel syndrome, radiculopathy)\n* Severe psychiatric conditions (depression, bipolar disorder, substance abuse)\n* Active uncontrolled infections requiring systemic antibiotics\u002Fantifungals\u002Fantivirals (≥ CTCAE Grade 2)\n* Active hepatitis or significant liver dysfunction not meeting inclusion criteria\n* Renal failure requiring dialysis\n* Immunodeficiency or history of organ transplantation\n* Severe nausea, headache, fatigue, or other debilitating symptoms\n* Active tuberculosis or uncontrolled pleural\u002Fpericardial effusion\u002Fascites\n* Hypersensitivity to monoclonal antibodies or study device components\n* Participation in other clinical trials within 4 weeks\n* Known bleeding or coagulation disorders or receiving thrombolytic therapy\n* Any other condition judged by the investigator to preclude safe participation","ALL","18 Years","75 Years",{"count":64,"type":65},58,"ESTIMATED","INTERVENTIONAL",[68],"NA","This multicenter, prospective phase II clinical trial aims to evaluate the efficacy and safety of medical compression stockings in preventing peripheral neuropathy induced by antibody-drug conjugates (ADCs) containing monomethyl auristatin E (MMAE) in patients with advanced cancers, including urothelial carcinoma. Eligible participants will have no baseline ≥ grade 1 neuropathy and will be scheduled to receive MMAE-containing ADC therapy. A total of 58 patients will be enrolled and followed for 24 months. In this self-controlled design, the left foot will be fitted with a medical compression stocking while the right foot remains uncovered, starting 15 minutes before infusion and continuing until 15 minutes after infusion (total duration: 120 minutes). Peripheral neuropathy will be assessed before treatment, after cycle 3, within 1 week after treatment completion, and 1 month after completion, using CTCAE v5.0 and patient-reported questionnaires (QLQ-C30 and FACT-GOG-NTx). Toe temperature will be measured to assess local microcirculation changes. The study will also monitor compression-related adverse events. The results will provide evidence for preventive strategies to reduce ADC-induced peripheral neuropathy and improve patients' quality of life.",[71,72,73,74],"Urothelial Carcinoma","Advanced Solid Tumors","Chemotherapy-Induced Peripheral Neuropathy","Antibody-drug Conjugates",[76,77,78,79,80,81],"Antibody-Drug Conjugates","Peripheral Neuropathy Prevention","Compression Stockings","Advanced Cancer","Quality of Life","Mechanical Compression Therapy","2025-09-11",{"date":84,"type":85},"2025-09-15","ACTUAL",{"date":87,"type":85},"2025-08-30",{"date":89,"type":65},"2026-07-01",{"name":51,"class":6},1]