Urothelial CarcinomaNCT07164950
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients
A study testing Medical-grade compression stocking in people with Urothelial Carcinoma and Advanced Solid Tumors, run by Sheng Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urothelial Carcinoma, Advanced Solid Tumors, Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Medical-grade compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 1 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Dr. Wan, 08602164175590, wanofficial@foxmail.com
About this study
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
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
- Urothelial Carcinoma, Advanced Solid Tumors, Chemotherapy-Induced Peripheral Neuropathy, Antibody-drug Conjugates
- Being tested
- Medical-grade compression stocking
- Keywords
- Antibody-Drug Conjugates, Peripheral Neuropathy Prevention, Compression Stockings, Advanced Cancer, Quality of Life, Mechanical Compression Therapy
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical-grade compression stockingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Compression Stocking Arm | Experimental | Each participant will wear a medical-grade compression stocking (Class II, 20-30 mmHg) on the assigned foot throughout the entire treatment period with antibody-drug conjugates (ADCs). Stockings are worn daily except during bathing. Receives: Device: Medical-grade compression stocking |
| Control Arm (No Stocking) | No intervention | The contralateral foot will not receive any compression stocking and will be observed under the same ADC treatment conditions. Each participant serves as their own control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: Measured at baseline, after the 3rd treatment cycle, at treatment completion, and 1 month after treatment completion.
Toe Temperature Changes (Infrared Thermography)
Change in toe temperature measured using infrared thermography, as an indicator of local microcirculation changes.
Measured: Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start30 Aug 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Self-controlled, within-subject comparison: left foot receives compression stocking, right foot serves as control.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164950
- Sponsor's protocol ID
- CIPN-ADC-002
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No