Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059772) titled 'Exploratory Study on Postoperative Tongue Electrical Stimulation for Esophageal Cancer' on Nov. 13.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kasai Medical University
Condition:
Condition - Esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate the effects of electrical stimulation of the tongue from the day after surgery until oral intake is initiated in patients with esophageal cancer.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Tongue electrical stimulation therapy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with pathologic esophageal cancer
Patients scheduled to undergo subtotal esophagectomy
Patients who have been fully informed about their participation in this study, and who have given their free and voluntary consent based on their full understanding of the study
Key exclusion criteria - Patients who underwent combined pharyngolaryngeal resection
Patients with a history of head and neck cancer treatment
Patients with communication difficulties, such as those unable to understand the purpose of the study
Patients deemed unsuitable as research subjects by the principal investigator
Target Size - 12
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 20 Day
Date of IRB - 2025 Year 08 Month 26 Day
Anticipated trial start date - 2025 Year 11 Month 17 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=R000068348
Disclaimer: Curated by HT Syndication.
