Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients

NCT ID: NCT07164950

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2026-07-01

Brief 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Compression Stocking Arm

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.

Group Type: EXPERIMENTAL

Medical-grade compression stocking

Intervention Type: DEVICE

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.

Control Arm (No Stocking)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheng Zhang

OTHER

Sponsor Role: lead

Responsible Party

Sheng Zhang

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Sheng Zhang, PhD

Role: CONTACT

568841700@qq.com

86+18017317442

Facility Contacts

Dr. Wan

Role: primary

wanofficial@foxmail.com

08602164175590

Other Identifiers

CIPN-ADC-002

Identifier Type: -

Identifier Source: org_study_id