Colon cancer including RS cancer
Conditions
Interventions
Oral administration of test drug (Daikenchuto) 5.0g per dose as a general rule (2.5g/pack x 2 packs) t.i.d. before meals.
May decrease dosage to 7.5g/day (2.5g/pack x 3 packs) according to patient`s
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who qualify for curative colonic resection (solely via laparotomy) for colon cancer (including rectosigmoidal region) Preoperative staging of disease: I, II, IIIa, IIIb TNM category distribution: T=1-3, N=0-2, M=0 2) PS (ECOG Performance Status Scale): 0, 1 3) Patients who can orally administration of Daikenchuto 4) Age: over 20 yo. 5) Gender: no specification 6) Inpatient/Outpatient: Inpatient 7) Patients who can provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with a history of endoscopic surgery 2) Patients with a history of laparoscopic surgery 3) Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn disease) 4) Patients requiring emergency surgery 5) Patients with double cancer 6) Patients with serious liver disorder 7) Patients with serious renal disorder 8) Patients with history of laparotomy and peritonitis (excludes surgery for appendicitis) 9) Patients who are taking other Kampo formulation(s) 10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 11) Others, including patients who are unfit for the study as determined by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Time to first defecation (hr) after nasogastric tube removal 2)Postoperative frequency of defecation (number of times/day) 3)Postoperative stool form (Bristol Stool Form Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) GSRS Score 2) FACT-C Score 3) CRP 4) Incidence of postoperative intestinal obstruction | — |
Countries
Japan
Outcome results
None listed