Tokyo, May 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061494) titled 'Investigation of rehabilitation for the dysesthesias by chemotherapy induced peripheral neuropathy' on May 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Nagasaki University

Condition: Condition - Chemotherapy-induced peripheral neuropathy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this exploratory study is to examine the short- and long-term effects of dysesthesia-matched transcutaneous electrical nerve stimulation combined with standard physical therapy in patients with chemotherapy-induced peripheral neuropathy, and to clarify its effects on numbness, pain, sensory disturbance, motor impairment, and interference with daily activities. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The study consists of a 1-week baseline phase with standard physical therapy alone, a 1-month intervention phase with dysesthesia-matched TENS combined with standard physical therapy, and a 1-month follow-up phase without TENS. During the intervention phase, dysesthesia-matched TENS will be delivered for 60 minutes per session, once weekly, for a total of four sessions.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1) Outpatients with chemotherapy-induced peripheral neuropathy in the hands and/or feet; 2) age under 80 years; 3) at least 3 months after completion of chemotherapy; 4) diagnosis of chemotherapy-induced peripheral neuropathy by a physician; 5) numbness or pain intensity of 3/10 or higher on the Numerical Rating Scale; 6) ability to provide written informed consent; and 7) permission for electrical stimulation therapy from the attending physician. Key exclusion criteria - 1) Cognitive impairment defined as a Mini-Mental State Examination score of 24 or lower; 2) peripheral neuropathy before chemotherapy, such as neuropathy due to diabetes or central nervous system disease; 3) implanted electrical devices such as a pacemaker; 4) refusal by the participant or family to continue participation during the study; and 5) worsening physical condition or other conditions judged to make continuation of assessment or intervention inappropriate. Target Size - 15

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 04 Month 04 Day Date of IRB - 2026 Year 04 Month 06 Day Anticipated trial start date - 2026 Year 05 Month 08 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070365

Disclaimer: Curated by HT Syndication.