UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan colorectal tumor prevention study: randomized controlled trial of curcumin
Title of the study (Brief title)	Japan colorectal tumor prevention study: randomized controlled trial of curcumin (J-CAP-C)
Region	Japan

Condition
Condition	colorectal tumor
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the colorectal cancer preventive effect of curcumin a double-blind randomized study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	The occurrence of a colorectal tumor (adenoma or cancer) is selected as the primary endpoint.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	curucmin 360mg/day
Interventions/Control_2	placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion 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
Key exclusion 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
Target sample size	600

Research contact person
Name of lead principal investigator	Tetsuji Takayama
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Gastroenterology and Oncology
Address	2-50-1 Kuramotocho Tokushima City, Japan
TEL	088-631-3111
Email	takayama@tokushima-u.ac.jp

Public contact
Name of contact person	Hideki Ishikawa
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular-Targeting Cancer Prevention
Address	3-2-17 2F Imabashi Tyuo-ku Osaka City, Japan
TEL	06-6202-6566
Homepage URL
Email	cancer@gol.com

Sponsor
Institute	Management Committee
Institute
Department

Funding Source
Organization	THERAVALUES CORPORATION
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 24 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 26 Day
Last modified on	2017 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021537