Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following colon surgery(a randomized, double-blind, multi-center, placebo-controlled study)

Phase 3

• Conditions: Colon cancer including RS cancer

• Registration Number: JPRN-UMIN000001592
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified