Colorectal Cancer
Conditions
Interventions
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.
Sponsors
Sapporo Medical University School of Medicine First Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with stage II or III colorectal cancer (confirmed histologically and cytologically) who had surgical resection 2.Patients who do not have concomitant, active double or multiple cancer 3.Age (at the time of informed consent): between 20 and 79 years old 4.Gender: no specification 5.Consultation division: no specification 6.Patients who have signed a written, informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMakoto Meguro
Sapporo Medical University School of Medicine First Department of Surgery
Outcome results
None listed