Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urot… (NCT07164950) | Clinical Trial Compass
RecruitingNot Applicable
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
China58 participantsStarted 2025-08-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0)
Timeframe: 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.