Clinical Trial: Exploratory Study on the Prevention of Lower-Limb Skeletal Muscle Mass Loss Using Perioperative Electrical Muscle Stimulation (EMS) in Patients Undergoing Lung Cancer Surgery (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062345) titled 'A Study of Electrical Muscle Stimulation (EMS) to Prevent Leg Muscle Loss in Patients Undergoing Lung Cancer Surgery' on Sept. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - National Hospital Organization Mito Medical Center

Condition: Condition - Lung cancer (patients scheduled of curative resection for lobectomy, segmentectomy, or partial resection ) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To perform a perioperative EMS intervention from before surgery through hospitalization (until discharge) in patients undergoing lung cancer surgery, to evaluate its feasibility and safety, and to evaluate the change in Skeletal Muscle Mass Index (SMI) before and after surgery, particularly the change in lower-limb skeletal muscle mass, thereby exploring the effect of perioperative EMS intervention on preventing loss of skeletal muscle mass. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Perioperative lower-limb EMS intervention using an electrical muscle stimulation device (SIXPAD Foot Fit 3, model SE-BZ, MTG Co., Ltd.; a contact-type device applied to the bare soles of the feet that requires no electrode attachment). 1. Preoperative intervention: From the day of admission (after obtaining consent) until the day before surgery. The built-in "Training" program (15 minutes, up to once daily) is used as the base protocol, supplemented as needed by the "Conditioning" program (12 minutes, up to twice daily). Stimulation intensity is adjusted within a 1-25 level range, according to patient tolerance, to a level causing no pain or discomfort. 2. Postoperative intervention: Starting on the day of surgery (only after at least 4 hours have elapsed since surgery and full recovery from anesthesia has been confirmed) or the day after surgery, continuing until discharge, using the same program and frequency. Intensity starts at a low level and is adjusted according to the patient's postoperative condition. 3. Site: Calf, anterior shin, and sole of the foot (the thigh is outside the scope of this device). 4. Administered by: A physician, nurse, or physical therapist. 5. As this is a single-arm study, there is no concurrent control arm; the institution's existing data (patients with no history of EMS) serve as a historical control.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients histologically or cytologically diagnosed with lung cancer, or clinically diagnosed with lung cancer 2. Patients scheduled to undergo lobectomy, segmentectomy, or partial resection 3. Patients aged 20 years or older at the time of consent 4. Patients with a Performance Status (PS) of 0-2 5. Patients able to walk preoperatively 6. Patients whose body composition can be assessed by BIA preoperatively 7. Patients who have provided written informed consent to participate in this study Key exclusion criteria - 1. Patients with an implanted cardiac pacemaker or implantable cardioverter defibrillator (ICD) 2. Patients with a prosthetic leg 3. Patients with active skin disease or a wound at the application site (sole of the foot or calf), or with a history of orthopedic surgery or implanted metal (e.g., bolts/plates) at the application site 4. Patients with an acute painful condition of the lower limb, such as fracture or osteoporosis 5. Patients with confirmed deep vein thrombosis (DVT), or judged preoperatively to be at markedly high risk of DVT 6. Patients with active infection before surgery 7. Patients with severe heart failure (NYHA class III or higher) 8. Patients currently undergoing, or within 4 weeks of completing, preoperative chemotherapy or radiotherapy for malignancy 9. Patients who are pregnant or may be pregnant 10. Patients with severe psychiatric illness that would make participation in the study difficult 11. Any other patient judged by the principal investigator to be inappropriate for participation in this study Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 15 Day Date of IRB - 2026 Year 07 Month 15 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071350

Disclaimer: Curated by HT Syndication.