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

NCT07164950 | Recruiting

• 1 other identifier: CIPN-ADC-002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

Antibody-Drug Conjugates; Peripheral Neuropathy Prevention; Compression Stockings; Advanced Cancer; Quality of Life; Mechanical Compression Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0)

  The proportion of patients who develop Grade ≥1 peripheral neuropathy, as assessed by CTCAE version 5.0.

  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.

Secondary Outcomes (5)

• Change in Quality of Life Scores (EORTC QLQ-C30)

  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.

• Peripheral Neuropathy Severity (FACT-GOG-NTx Scale)

  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.

• Left vs. Right Lower Limb Neuropathy Comparison (FACT-GOG-NTx Scale)

  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

• Incidence of Grade ≥2 Peripheral Neuropathy (CTCAE v5.0)

  Measured at baseline, after the 3rd treatment cycle, at treatment completion, and 1 month after treatment completion.

• Toe Temperature Changes (Infrared Thermography)

  Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days).

Study Arms (2)

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.

Device: Medical-grade compression stocking

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.

Interventions

Medical-grade compression stocking 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.

Compression Stocking Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Sheng Zhang: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Sheng Zhang, PhD

CONTACT

86+18017317442; 568841700@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: Self-controlled, within-subject comparison: left foot receives compression stocking, right foot serves as control.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 10, 2025
• Study Start: August 30, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

CN (1)