UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective exploratory study for evaluating the efficacy of taking ENEVO long term for gastric cancer patients after gastrectomy.
Title of the study (Brief title)	Prospective exploratory study for evaluating the efficacy of taking ENEVO long term for gastric cancer patients after gastrectomy.
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	There are many reports that body weight loss after gastrectomy cause lower completion rate of adjuvant chemotherapy. So it is suggested there is a need for nutrition intervention for gastric cancer patients after surgery. We will evaluate the efficacy of oral nutritional supplements using ENEVO to the gastric cancer patients after gastrectomy. And We will evaluate the efficacy of taking ENEVO everyday long term.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The body weight loss rate as compared to preoperative body weight at 24weeks after beginning to take ENEVO.
Key secondary outcomes	1.The body weight loss rate as compared to preoperative body weight at 52weeks after beginning to take ENEVO . 2.The maximum body weight loss rate as compared to preoperative body weight. 3.Nutritional assessment. 4.Incidence of adverse events. 5.In case of adjuvant chemotherapy,treatment completion rate.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ENEVO administration for 24weeks
Interventions/Control_2	ENEVO administration for 2weeks
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)The patient who diagnosed with histologically gastric cancer. 2)The patient who is more than 20 years old to below 75 years old. 3)The patient who received no existing treatment(including neoadjuvant chemotherapy) and are scheduled surgery in primary resection. 4)The patient who is PS(ECOG) from 0-2. 5)The patient who can be oral ingestion. 6)The patient who can obtain informed consent. 7)The patient who can write a diary exactly.
Key exclusion criteria	1)The patient who are overlapped cancer of synchronism or metachronous, or who are multiple cancer. 2)The patient who contraindicated of ENEVO. 3)The patient who are participating in other clinical trials. 4)The patient who is not suitable for this clinical study by researchers. 5)The patient who experienced severe postoperative complications(more than Grade3 of Clavien-Dindo classification).
Target sample size	60

Research contact person
Name of lead principal investigator	Shigeki Yamada
Organization	Fujita Health University
Division name	Department of clinical pharmacy
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL	0562-93-2111
Email	syamada@fujita-hu.ac.jp

Public contact
Name of contact person	Miyuki Ueno
Organization	Fujita Health University
Division name	Department of clinical pharmacy
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL	0562-93-2111
Homepage URL
Email	miyukioya28@gmail.com

Sponsor
Institute	Fujita Health University Hospital
Institute
Department

Funding Source
Organization	Fujita Health University Hospital
Organization
Division
Category of Funding Organization	Self funding
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 06 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 12 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 06 Month 16 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020661