Compression stockings to prevent peripheral neuropathy in patients receiving MMAE-containing ADCs for urothelial cancer
Official 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
Run by Fudan University · NCT07164950 · Data updated 2026-11-12
This study will test whether wearing a medical compression stocking on one foot during antibody–drug conjugate (MMAE-containing) infusions can prevent peripheral neuropathy in adults with advanced urothelial carcinoma or other cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | August 30, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT07164950 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed advanced malignancy (including urothelial carcinoma) scheduled to start MMAE-containing ADC therapy, ECOG 0–2, no baseline peripheral neuropathy ≥ Grade 1, adequate organ function, and expected survival ≥3 months.
✕Probably not a fit
Patients with pre-existing neuropathy ≥ Grade 1, severe diabetes or peripheral vascular disease, neurological compression disorders, or those unable to tolerate or wear compression stockings are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective, self-controlled phase II study enrolling 58 patients who will receive MMAE-containing ADC therapy. Each participant will wear a medical-grade compression stocking on the left foot starting 15 minutes before infusion and continuing until 15 minutes after infusion (total 120 minutes), while the right foot remains uncovered. Peripheral neuropathy will be measured before treatment, after cycle 3, within one week after treatment completion, and one month after completion using CTCAE v5.0 and patient-reported QLQ-C30 and FACT-GOG-NTx questionnaires. Participants will be followed for 24 months for safety and neuropathy outcomes.
Why it matters
Potential benefit: If successful, this simple, low-risk measure could reduce the frequency or severity of ADC-induced peripheral neuropathy and help preserve patient quality of life.
How similar studies have gone: Using compression or limb-protection approaches to prevent chemotherapy-related neuropathy has shown mixed results in other chemotherapy settings and the application specifically to ADC-induced neuropathy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
Study contacts
- Study coordinator: Sheng Zhang, PhD
- Email: 568841700@qq.com
- Phone: 86+18017317442
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.