Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062575) titled 'A Study to Investigate Whether Hand Cooling Can Prevent Numbness of the Hands Caused by Anticancer Therapy (EVP)' on Sept. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Sakai city medical center

Condition: Condition - urothelial carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether localized hand cooling can prevent sensory peripheral neuropathy induced by monomethyl auristatin E (MMAE), the payload of enfortumab vedotin (EV), in patients receiving enfortumab vedotin plus pembrolizumab (EVP) as first-line therapy for locally advanced or metastatic urothelial carcinoma, using a within-patient self-controlled design comparing the two hands of each patient. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - On the intervention side (dominant hand), localized hand cooling is performed on each EV administration day (Day 1 and Day 8 of every cycle) by applying a frozen glove over a thin cotton glove for approximately 90 minutes in total, from 30 minutes before infusion, during infusion, until 30 minutes after the end of infusion. The control side (non-dominant hand) receives no application. Cooling is repeated on every EV administration day during EVP therapy, up to 6 months or until the end of treatment.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Histologically confirmed urothelial carcinoma (including variant histology). (2) Scheduled to start enfortumab vedotin plus pembrolizumab (EVP) as first-line therapy for locally advanced or metastatic urothelial carcinoma. (3) ECOG Performance Status 0 to 2. (4) Age 20 years or older at the time of consent. (5) Written informed consent for study participation has been obtained. Key exclusion criteria - (1) Peripheral neuropathy of Grade 1 or higher at baseline (e.g., diabetic neuropathy or pre-existing chemotherapy-induced peripheral neuropathy). (2) Severe circulatory disorder or skin disease of the fingers/hands (e.g., severe Raynaud's phenomenon, cold intolerance, cryoglobulinemia) for which cooling is deemed inappropriate. (3) Regular use of drugs that may mask neuropathic symptoms (e.g., duloxetine, pregabalin, mirogabalin). (4) Any other condition judged inappropriate by the principal investigator or sub-investigators. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 16 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2031 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071625

Disclaimer: Curated by HT Syndication.