Colon cancer
Conditions
Interventions
A group: Oral administration of test drug (daikenchuto) 5.0 g per dose as a general rule (15 g/day, t.i.d., before meals) from postoperative day 2 to postoperative day 28.
B group: Non-treatment.
Sponsors
Department of gastrointestinal surgery, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, a patient must meet all of the following criteria. 1) Patients who qualify for curative resection for colon cancer. Preoperative TNM category distribution: T=1a-3, N=0-2,M=0 2) Patients who suffer from abdominal pain and distention on postoperative day 1. 3)PS (ECOG Performance Status Scale): 0-2 4) Age: over 20 yo. 5) Gender: no specification 6) Inpatient/Outpatient: Inpatient 7) Patients who can orally take Daikenchuto 8) Patients who can provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who can orally take Daikenchuto on postoperative day 1. 2) Patients with history of laparotomy 3) Patients with history of ileum. 4) Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease. 5) Patients with concomitant endometriosis 6) Patients requiring emergency surgery 7) Patients who have been treated or will be treated by chemotherapy or radiotherapy for primary disease 8) Patients with serious concomitant diseases 9) Patients who took prohibited concomitant drugs 4 weeks before treatment. 10) Patients with history of allergy for other Kampo formulation(s) 11) Patients with infection of HBV or HCV 12) Others, including patients who are unfit for the study as determined by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Numerical Rating Scale of abdominal pain 2) Numerical Rating Scale of abdominal distention 3) Gastrointestinal Quality of Life Index (GIQLI) | — |
Countries
Japan
Outcome results
None listed