UMIN-CTR Clinical Trial

Public title

Japan colorectal tumor prevention study:
randomized controlled trial of curcumin

Acronym

Japan colorectal tumor prevention study:
randomized controlled trial of curcumin
(J-CAP-C)

Scientific Title

Japan colorectal tumor prevention study:
randomized controlled trial of curcumin

Scientific Title:Acronym

Japan colorectal tumor prevention study:
randomized controlled trial of curcumin
(J-CAP-C)

Region

Japan

Condition

colorectal tumor

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuji Takayama

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Department of Gastroenterology and Oncology

Zip code

Address

2-50-1 Kuramotocho Tokushima City, Japan

TEL

088-631-3111

Email

takayama@tokushima-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideki Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular-Targeting Cancer Prevention

Zip code

Address

3-2-17 2F Imabashi Tyuo-ku Osaka City, Japan

TEL

06-6202-6566

Homepage URL

Email

cancer@gol.com

Institute

Management Committee

Institute

Department

Personal name

Organization

THERAVALUES CORPORATION

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

03

Month

24

Day

Date of IRB

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

Other related information

Registered date

2015

Year

08

Month

26

Day

Last modified on

2017

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021537