Clinical study to examine the effectiveness of Juzentaihoto in postoperative recovery for colorectal cancer patients - A research investigating the role of cell-mediated immunity in recovery

UMIN ID: UMIN000001235

Registered date:08/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 2008/07/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Juzentaihoto is administered orally 7.5g/day in 2-3 dosages, before or between meals Total duration of test: 24 weeks starting from one week after surgery
Juzentaihoto is not administered.

Outcome(s)

• Primary Outcome: 1.ECOG's Performance Status (ECOG=Eastern Cooperative Oncology Group) 2.Weight 3.QOL-ACD (The QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs) 4.Hematological test (RBC, Hb, Ht, WBC, differential leukocyte count, PLT) 5.Serum albumin 6.Cell-mediated immunity (HLA-DR/CD3, CD11b/CD8, NK-cell activity) 7.Blood cytokine (IL-6, IL-10, IL-12, IL-18, TGF-beta, IFN-gamma) 8.Carcinoembryonic antigen (CEA) 9.Recurrence of cancer 10.Metastasis of cancer 11.Duration of anticancer drug therapy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1.Patients who did not have complete resection of their bowels 2.Patients who took Traditional Japanese Medicine within four weeks of their surgery 3.Patients who are unable to take the test medication one week after the surgery 4.Patients with preoperative laboratory values falling within the ranges as described below, and their main organs (bone marrow, heart, lungs, kidneys and liver) show advanced, functional disorders: *WBC<or=4,000/mm3 or 12,000/mm3<or=WBC *Platelets<or=100,000/mm3 *Hemoglobin<or=10g/dl *AST (SGOT serum glutamic-oxaloacetic transaminase) > 2x above upper normal range *ALT (SGPT serum glutamic-pyruvic transaminase) > 2x above upper normal range *Serum total bilirubin>or=2.0mg/dl *BUN<or=25mg/dl *Serum creatinine >or=1.5mg/dl 5.Patients who have serious, postoperative complications including infection, diarrhea (watery stool), tube paralysis, bowel obstruction with pleural effusion, ascites or hydropericardium 6.Patients who have clinically active inflammation or complication 7.Patients who are pregnant or are possibly pregnant 8.Patients who fail to meet the eligibility criteria for the study 9.Patients who are unable to sign a written consent 10. Patients who are determined to be unfit for the study by the physician in charge of the research

Related Information

• Primary Sponsor: Sapporo Medical University School of Medicine First Department of Surgery
• Source(s) of Monetary Support: Tsumura Co., Ltd.