Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-29 @ 6:47 AM
Study NCT ID:
NCT07164950
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Self-controlled, within-subject comparison: left foot receives compression stocking, right foot serves as control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-08-10', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0)', 'timeFrame': 'Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion.', 'description': 'The proportion of patients who develop Grade ≥1 peripheral neuropathy, as assessed by CTCAE version 5.0.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life Scores (EORTC QLQ-C30)', 'timeFrame': 'Baseline; At the end of Cycle 3 (each cycle = 28 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion.', 'description': 'Change in patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100; higher scores indicate better quality of life.'}, {'measure': 'Peripheral Neuropathy Severity (FACT-GOG-NTx Scale)', 'timeFrame': 'Baseline; At the end of Cycle 3 (each cycle = 28 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion.', 'description': 'Severity of chemotherapy-induced neuropathy symptoms assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTx) subscale. Scores range from 0 to 44; higher scores indicate more severe neuropathy.'}, {'measure': 'Left vs. Right Lower Limb Neuropathy Comparison (FACT-GOG-NTx Scale)', 'timeFrame': 'Baseline; At the end of Cycle 3 (each cycle = 28 days); At treatment completion (within 7 days of last ADC dose); 1 month (±7 days) after treatment completion', 'description': 'Assessment of lower limb neuropathy symptoms, focusing on sensory and motor impairment, using a 4-item subscale from the FACT-GOG-NTx questionnaire. Each item is scored from 0 to 4, with total scores ranging from 0 to 16; higher scores indicate more severe neuropathy.'}, {'measure': 'Incidence of Grade ≥2 Peripheral Neuropathy (CTCAE v5.0)', 'timeFrame': 'Measured at baseline, after the 3rd treatment cycle, at treatment completion, and 1 month after treatment completion.', 'description': 'Proportion of patients developing Grade 2 or higher peripheral neuropathy as per CTCAE 5.0 criteria.'}, {'measure': 'Toe Temperature Changes (Infrared Thermography)', 'timeFrame': 'Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days).', 'description': 'Change in toe temperature measured using infrared thermography, as an indicator of local microcirculation changes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibody-Drug Conjugates', 'Peripheral Neuropathy Prevention', 'Compression Stockings', 'Advanced Cancer', 'Quality of Life', 'Mechanical Compression Therapy'], 'conditions': ['Urothelial Carcinoma', 'Advanced Solid Tumors', 'Chemotherapy-Induced Peripheral Neuropathy', 'Antibody-drug Conjugates']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/taxane 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/antifungals/antivirals (≥ 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/pericardial effusion/ascites\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'}, 'identificationModule': {'nctId': 'NCT07164950', 'briefTitle': 'Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CIPN-ADC-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compression Stocking Arm', 'description': '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.', 'interventionNames': ['Device: Medical-grade compression stocking']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm (No Stocking)', 'description': '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.'}], 'interventions': [{'name': 'Medical-grade compression stocking', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Compression Stocking Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dr. Wan', 'role': 'CONTACT', 'email': 'wanofficial@foxmail.com', 'phone': '08602164175590'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Sheng Zhang, PhD', 'role': 'CONTACT', 'email': '568841700@qq.com', 'phone': '86+18017317442'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheng Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Sheng Zhang', 'investigatorAffiliation': 'Fudan University'}}}}