Japan colorectal tumor prevention study

JRCT ID: jRCTs061180079

Registered date:20/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: colorectal tumor
• Date of first enrollment: 07/07/2016
• Target sample size: 600
• Study type: Interventional
• Intervention(s): 2 Caps of Theracurmin or placebo given on twice per day for 2 years

Outcome(s)

• Primary Outcome: The occurrence of a colorectal tumor (adenoma or cancer) is selected as the primary endpoint.

Secondary Outcome

# questionnaire
# The occurrence of tumor (adenoma or cancer) with exception of colon

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Candidate patients have to meet all the following inclusion criteria to participate in the study.
# Patients with at least one colorectal tumor (intramucosal cancer and adenoma) as confirmed by histological diagnosis, all of which have been removed endoscopically (at any time)
# Patients with known history of all endoscopic treatments (including histological diagnosis) of colorectal tumors
# Patients who have undergone total colonoscopy at least twice
# Patients with clean colon as confirmed by total colonoscopy within 3 months before the study

Exclude criteria

# Patients with a medical history of submucosal or deeper colorectal cancer.
# Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin, Persantin and NOAC.
# Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study).
# Patients with familial colorectal adenoma.
# Patients with any existing cancer at the time of participation in the study.
# Patients with known allergy to curcumin.
# Patients currently taking anticancer drugs.
# Women who are or may be pregnant during the study period.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.
# Patients with ulcerative colitis or Crohn's disease
# Patients with bleeding tendency or platelet count less than 70,000.
# Patient taking turmeric as a supplement.
# Patient deemed inappropriate by a doctor

Related Information

• Primary Sponsor: Takayama Tetsuji
• Source(s) of Monetary Support: THERAVALUES corporation,Ministry of Agriculture, Forestry and Fisheries
• Secondary ID(s): UMIN000018817