UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on the usefulness of fucoidan-containing food intake for early or unresectable advanced gastric cancer patients
Title of the study (Brief title)	The study on the usefulness of fucoidan intake for gastric cancer patients
Region	Japan

Condition
Condition	early or unresectable advanced gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the effects on immune function and so on by intaking food including fucoidan for early gastric cancer patients or unresectable advanced gastric cancer patients with the standard chemotherapy as first-line treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess immune monitoring such as cytokines, QOL evaluation and intestinal flora analysis.
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	Treatment
Type of intervention	Food
Interventions/Control_1	To intake fucoidan-containing food every day.
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	1) Histologically confirmed gastric cancer. 2) Patients informed diagnosis of their disease. 3) Aged from 20 over years. 4) Grade 0 to 2 in performance status (ECOG). 5) In early gastric cancer patients, patients with confirmed the curative resection with endoscopic treatment. 6) In advanced gastric cancer patients, patients who are scheduled to newly primary chemotherapy. 7) Expected to be alive at least six months after informed consent in advanced gastric cancer patients. 8) Having written informed consent.
Key exclusion criteria	1) Presence of severe complications (heart failure, liver desease, renal desease). 2) Presence of infectious disease. 3) Taking the drug affecting immune system such as steroid and immunosuppresant. 4) Taking the supplement affecting immune system. 5) Inappropriate patients for study judged by the physicians.
Target sample size	30

Research contact person
Name of lead principal investigator	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Molecular Gastroenterology and Hepatology
Address	465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Molecular Gastroenterology and Hepatology
Address	465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	ynaito@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	TAKARA BIO, INC
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	京都府立医科大学附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 09 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	2014 Year 07 Month 02 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016824