Actively Recruiting
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
Led by Sheng Zhang · Updated on 2025-09-15
58
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced malignancy eligible for MMAE-containing ADC therapy (e.g., EV, DV, BV)
- ECOG performance status 0-2
- No baseline peripheral neuropathy grade 1 or higher (CTCAE v5.0)
- Stable tumor status without use of other neurotoxic drugs in the past 2 months
- Adequate organ function according to protocol
- Expected survival of at least 3 months
- Ability and willingness to comply with study procedures and provide written informed consent
You will not qualify if you...
- Poor compliance or inability to follow protocol
- Pre-existing peripheral neuropathy grade 1 or higher from prior platinum or taxane treatment
- Severe diabetes or peripheral vascular disease
- Neurological disorders causing nerve compression (e.g., carpal tunnel syndrome, radiculopathy)
- Severe psychiatric conditions such as depression, bipolar disorder, or substance abuse
- Active uncontrolled infections requiring systemic antibiotics, antifungals, or antivirals (grade 2 or higher)
- 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 condition judged by the investigator to preclude safe participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
S
Sheng Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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