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
- Are there results?
- Not yet: the study is under way
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)
Show all 15Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07164950
- Acronym / sponsor ID
- CIPN-ADC-002
- Conditions
- Urothelial Carcinoma, Advanced Solid Tumors, Chemotherapy-Induced Peripheral Neuropathy, Antibody-drug Conjugates
- Keywords
- Antibody-Drug Conjugates, Peripheral Neuropathy Prevention, Compression Stockings, Advanced Cancer, Quality of Life, Mechanical Compression Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sheng ZhangUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Self-controlled, within-subject comparison: left foot receives compression stocking, right foot serves as control.
| Arm | Type | Receives |
|---|---|---|
| Compression Stocking Arm | Experimental | Device: Medical-grade compression stockingEach 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical-grade compression stockingA 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. | Device | Compression Stocking Arm |
Primary outcome
Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0)
Time frame: 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.
The proportion of patients who develop Grade ≥1 peripheral neuropathy, as assessed by CTCAE version 5.0.
5 secondary outcomes
Change in Quality of Life Scores (EORTC QLQ-C30)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Measured at baseline, after the 3rd treatment cycle, at treatment completion, and 1 month after treatment completion.
Toe Temperature Changes (Infrared Thermography)
Time frame: Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Zhang, PhD (86+18017317442, 568841700@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥1 Peripheral Neuropathy (CTCAE v5.0) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.