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

Effects of Rikkunshito Administration During Neoadjuvant Chemotherapy for Esophageal Cancer

Inaki Noriyuki

Kanazawa Univesity Hospital

13-1, Takaramachi, kanazawa, Ishikawa

n.inaki@med.kanazawa-u.ac.jp

Tsuji Toshikatsu

Kanazawa University Hospital

13-1, Takaramachi, kanazawa, Ishikawa

+81-76-265-2369

toshi_toshi25@yahoo.co.jp

Recruiting

May. 27, 2026

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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.

Both

esophageal cancer

Rikkunshito administration will be initiated on the first day of neoadjuvant chemotherapy and will be continued throughout the course of neoadjuvant chemotherapy. After completion of neoadjuvant chemotherapy, rikkunshito will be continued until immediately before surgery.

esophageal cancer

Rikkunshito, administration

Rate of body weight change before and after treatment, defined as the change from before the initiation of chemotherapy to the completion of the planned chemotherapy.

The following parameters will be evaluated before and after treatment:
(1) Difference in body weight loss
(2) Rate of change in skeletal muscle area (SMA)
(3) Rate of change in serum albumin
(4) Rate of change in lymphocyte count
(5) Rate of change in the Prognostic Nutritional Index (PNI)
(6) Rate of change in the Geriatric Nutritional Risk Index (GNRI)
(7) Incidence of chemotherapy-related adverse events (CTCAE Grade 2 or higher)
(8) Incidence of pseudoaldosteronism

+81-76-265-2048

May. 15, 2026

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