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.
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
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)
Crossover
Medical-grade compression stocking
DeviceA 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.
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.
Change in Quality of Life Scores (EORTC QLQ-C30)
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.
Peripheral Neuropathy Severity (FACT-GOG-NTx Scale)
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.
Left vs. Right Lower Limb Neuropathy Comparison (FACT-GOG-NTx Scale)
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.
Incidence of Grade ≥2 Peripheral Neuropathy (CTCAE v5.0)
Proportion of patients developing Grade 2 or higher peripheral neuropathy as per CTCAE 5.0 criteria.
Click on the lead sponsor to view all of their trials.
Sheng Zhang
Lead sponsor
Fudan University
Sponsor institution
