A Multicenter Study on the Effects of Rikkunshito Administration During Neoadjuvant Chemotherapy for Esophageal Cancer

未提供0 个研究点目标入组 210 人开始时间: 待定

适应症

试验速览

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•Patients who meet all of the following criteria will be eligible:
•(1) Histologically confirmed esophageal squamous cell carcinoma
•(2) Clinical stage II or III disease scheduled to receive neoadjuvant chemotherapy followed by surgery
•(3) Age 20 years or older at the time of consent
•(4) ECOG performance status of 0 or 1
•(5) Written informed consent obtained from the patient after adequate explanation and understanding. Historical control cases will be disclosed by an opt-out method.

•Patients who meet any of the following criteria will be excluded:
•(1) Difficulty in oral intake due to esophageal stenosis or swallowing dysfunction
•(2) Presence of active synchronous malignancy
•(3) Use of any Kampo medicine within 2 weeks prior to the initiation of Rikkunshito
•(4) History of hypersensitivity to Kampo medicines
•(5) Respiratory disease with Hugh-Jones classification grade II or higher
•(6) Unstable angina within the past 3 weeks or a history of myocardial infarction within the past 6 months
•(7) Uncontrolled hypertension
•(8) Uncontrolled diabetes mellitus
•(9) Pregnant, possibly pregnant, or breastfeeding women
•(10) Patients judged to be inappropriate for participation by the investigator
•(11) Patients with hypokalemia (serum potassium level <3.5 mEq/L) detected on blood testing.

发起方

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