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

UMIN ID: UMIN000001592

Registered date:01/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colon cancer including RS cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 symptoms.

Oral administration of test drug (placebo) 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 symptoms.

Outcome(s)

Primary Outcome

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 Outcome

1) GSRS Score
2) FACT-C Score
3) CRP
4) Incidence of postoperative intestinal
obstruction

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer