Actively Recruiting
Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Patients With Urothelial Carcinoma in a Phase II Clinical Trial
Led by Sheng Zhang · Updated on 2025-09-15
58
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of medical compression stockings to prevent peripheral neuropathy caused by antibody-drug conjugates (ADCs) containing monomethyl auristatin E (MMAE) in patients with advanced cancers, including urothelial carcinoma. This phase II clinical trial aims to evaluate the safety and effectiveness of these stockings in reducing nerve damage during cancer treatment. The study will enroll 58 patients without existing grade 1 or higher neuropathy and follow them for 24 months. Participants will wear a medical-grade compression stocking on the left foot during ADC treatment cycles, while the right foot will not be covered, serving as a control. The stocking is worn starting 15 minutes before infusion and continuing until 15 minutes after infusion, approximately 120 minutes in total. Stockings are to be worn daily throughout the treatment period except during bathing. This self-controlled design allows comparison between the compressed and non-compressed limbs. During the study, peripheral neuropathy will be assessed before treatment, after the third treatment cycle, at treatment completion, and one month after treatment ends. Evaluations include clinical grading of neuropathy, patient-reported quality of life and neuropathy questionnaires, and toe temperature measurements to monitor local blood flow changes. The study will also track any adverse effects related to wearing compression stockings. Overall, participants will be involved in regular assessments to understand the stockings' role in preventing chemotherapy-induced nerve damage.
CONDITIONS
Brief 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
- ECOG performance status of 0 to 2
- No baseline peripheral neuropathy grade 1 or higher
- Stable tumor status without other neurotoxic drugs in the past 2 months
- Adequate organ function as defined by blood counts, liver, and kidney tests
- Expected survival of 3 months or more
- Ability and willingness to comply with study procedures and provide 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 such as carpal tunnel syndrome or radiculopathy
- Severe psychiatric conditions including 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, or 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 that the investigator judges unsafe for participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 cycles of 28 days each
Participants wear a medical-grade compression stocking on one foot daily during antibody-drug conjugate treatment cycles to prevent peripheral neuropathy, while the other foot is observed without intervention.
Visits at baseline, end of Cycle 3, and at treatment completion
Duration - 1 month (±7 days)
Participants are monitored for peripheral neuropathy and quality of life for 1 month after treatment completion.
1 visit approximately 1 month after treatment completion
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
S
Sheng Zhang, PhD
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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