UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Broccoli Sprouts Intervention on Chemoprevention against Colon Cancer
Title of the study (Brief title)	BS-CCPT (Broccoli Sprouts-Colon Cancer Prevention Trial)
Region	Japan

Condition
Condition	Colonic Adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estabish effective method for chemoprevention against colon cancer by dietary intake of broccoli sprouts
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Number of aberrant crypt foci(ACF) in rectal mucosa
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: 6 months Total Amount:4,500 gram(=50 gram x 90) Single dose: 50 gram/time Frequency:once per 2 days
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Endoscopically diagnosed colonic adenoma
Key exclusion criteria	Patients with active or inactive IBD NSAIDs User Patients taking Warfarin Allergy to broccoli sprouts Paitients judged as inappropriate fo this study for some reasons by medical doctors
Target sample size	22

Research contact person
Name of lead principal investigator	Akinori Yanaka, MD and PhD
Organization	Faculty of Medicine, University of Tsukuba
Division name	Gastroenterology
Address	1-1-1Tennodai, Tsukuba-shi, Ibaraki-ken, 305-8575, Japan
TEL	0294-23-1111
Email	ynk-aki@md.tsukuba.ac.jp

Public contact
Name of contact person	Hideo Suzuki, MD and PhD
Organization	Univeristy of Tsukuba
Division name	Gastroenterology
Address	1-1-1Tennodai, Tsukuba-shi, Ibaraki-ken, 305-8575, Japan
TEL	029-853-3218
Homepage URL
Email	hideoszk@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba hospital, Hitachi Medical Education and Research Center
Institute
Department

Funding Source
Organization	University of Tsukuba hospital, Hitachi Medical Education and Research Center
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	2013 Year 10 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 24 Day
Anticipated trial start date	2011 Year 08 Month 25 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	2013 Year 10 Month 11 Day
Last modified on	2018 Year 05 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007094