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NCT Number: NCT07164950

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

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.

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Key information

Conditions

Urothelial Carcinoma Advanced Solid Tumors Antibody-drug Conjugates Carcinoma Carcinoma, Transitional Cell Chemotherapy-induced Peripheral Neuropathy Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)
  • Active hepatitis or significant liver dysfunction not meeting inclusion criteria
  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

Secondary outcomes

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

    Time frame: 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.

    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.

  2. Peripheral Neuropathy Severity (FACT-GOG-NTx Scale)

    Time frame: 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.

    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.

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

    Time frame: 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

    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.

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

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

    Proportion of patients developing Grade 2 or higher peripheral neuropathy as per CTCAE 5.0 criteria.

  5. Toe Temperature Changes (Infrared Thermography)

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

    Change in toe temperature measured using infrared thermography, as an indicator of local microcirculation changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Zhang, PhD

CONTACT

[email protected]

86+18017317442

Sponsors and collaborators

Lead sponsor

Sheng Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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