Phase II Study of Medical Compression Stockings to Prevent Peripheral Neuropathy in Adults Receiving Antibody-Drug Conjugates for Advanced Urothelial Carcinoma

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.

Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients