RecruitingNot ApplicableNCT07164950

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

Sponsor

Sheng Zhang

Enrollment

58 participants

Start Date

Aug 30, 2025

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma Chemotherapy Induced Peripheral Neuropathy Advanced Solid Tumors Antibody-drug Conjugates

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria15

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)
ECOG performance status 0-2
No baseline peripheral neuropathy ≥ Grade 1 (CTCAE v5.0)
Stable tumor status without other neurotoxic drugs in the past 2 months
Adequate organ function (blood counts, liver and kidney function) per protocol
Expected survival ≥ 3 months
Ability and willingness to comply with study procedures and provide written informed consent
Renal failure requiring dialysis
Immunodeficiency or history of organ transplantation
Severe nausea, headache, fatigue, or other debilitating symptoms
Active tuberculosis or uncontrolled pleural/pericardial effusion/ascites
Hypersensitivity to monoclonal antibodies or study device components
Participation in other clinical trials within 4 weeks
Known bleeding or coagulation disorders or receiving thrombolytic therapy
Any other condition judged by the investigator to preclude safe participation

Exclusion Criteria6

Poor compliance or inability to follow protocol
Pre-existing peripheral neuropathy ≥ Grade 1 from prior platinum/taxane treatment
Severe diabetes or peripheral vascular disease
Neurological disorders causing nerve compression (e.g., carpal tunnel syndrome, radiculopathy)
Severe psychiatric conditions (depression, bipolar disorder, substance abuse)
Active uncontrolled infections requiring systemic antibiotics/antifungals/antivirals (≥ CTCAE Grade 2)

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Interventions

DEVICEMedical-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.