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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical-grade compression stocking | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Zhang, PhD | Contact | 86+18017317442 | 568841700@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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Self-controlled, within-subject comparison: left foot receives compression stocking, right foot serves as control.
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| 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. | 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. | 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 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. | Baseline (within 7 days before treatment start); At the end of Cycle 3 (each cycle = 28 days, within 7 days). |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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