esophageal cancer esophageal cancer
Conditions
Interventions
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 chemo
Rikkunshito, administration
Sponsors
Inaki Noriyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactToshikatsu Tsuji
Kanazawa University Hospital
Outcome results
None listed