UMIN-CTR Clinical Trial

Basic information
Public title	The effect of amino acid administration on the reduction of muscle mass in patients undergoing gastrectomy
Acronym	The effect of amino acid administration on the reduction of muscle mass in patients undergoing gastrectomy
Scientific Title	The effect of amino acid administration on the reduction of muscle mass in patients undergoing gastrectomy
Scientific Title:Acronym	The effect of amino acid administration on the reduction of muscle mass in patients undergoing gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	A purpose of this study is to clarify the effect that perioperative management with leucine-rich amino acid and exercise improves postoperative course in gastric cancer surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	The ratio of skeletal muscle mass at 1 month after surgery to preoperative mass
Key secondary outcomes	The ratio of body weight at 1 month after surgery to preoperative weight Postoperative complications Postoperative hospital stay Nutritional parameters (albumin, transthyretin, total protein, lymphocyte counts) Ingestion rate of leucine-rich amino acid Continuation rate of postoperative adjuvant chemotherapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Oral intake of leucine-rich amino acid from POD-1 to POD 30.
Interventions/Control_2	Enhanced exercise from POD 1 to day of discharge.
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	85 years-old >=
Gender	Male
Key inclusion criteria	1)Patients with radical surgery is scheduled. 2)ASA(American Society of Anesthesiology)class 1-3. 3)T factor T1a-T4a. 4)Weight loss rate the month prior to surgery is within 10%. 5)Written informed consent must be obtained from patients.
Key exclusion criteria	1)Patients with severe complications. 2)Requiring resection the other organs except the gallbladder. 3)Patients with infection in progress. 4)Emergency surgery. 5)Patients with uncontrolled diabetes. 6)Patients enrollment to the study is determined to be inappropriate.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhisa Uchiyama
Organization	Osaka medical college
Division name	General and Gastroenterological Surgery
Zip code
Address	2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL	072-683-1221
Email	uchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryo Tanaka
Organization	Osaka medical college
Division name	General and Gastroenterological Surgery
Zip code
Address	2-7 Daigaku-machi, Takatsuki city Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	sur148@osaka-med.ac.jp

Sponsor
Institute	Osaka medical college, General and Gastroenterological Surgery
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪医科大学　一般・消化器外科

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 27 Day
Date of IRB	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry	2021 Year 04 Month 30 Day
Date trial data considered complete	2021 Year 04 Month 30 Day
Date analysis concluded	2021 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 18 Day
Last modified on	2020 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031015