UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Title of the study (Brief title)	A study for evaluating effects of ingested amino acids, cystine and theanine, on postoperative amount of activity.
Region	Japan

Condition
Condition	Open distal gastrectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study whether preoperative administration of amino acids, cystine and theanine, accelerate recovery from postoperative reduction of activity amount.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Changes in amount of activity from 2 days before to 1 week after surgery measured using wristwatch-type motion logger.
Key secondary outcomes	Hematological and blood biochemistry indices before and 1, 3, 7, 14days after surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing 700mg of cystine and 280mg of theanine once daily for 10 days from 2days before until 7days after surgery.
Interventions/Control_2	No ingestion of supplement instead of the cystine and theanine.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Received a written informed consent by patient's self-determination. 2.Scheduled to receive open distal gastrectomy. 3.From 20 to less than 80 years old. 4.No severe complication before surgery.
Key exclusion criteria	1.Phenyl ketonuria. 2.Active infection. 3.Poorly controlled hypertension. 4.Poorly controlled diabetes. 5.Clinically important cardiac disease. 6.Severe pulmonary disease(e.g. interstitial pneumonia, fibrosis, severe emphysema). 7.History of clinically important psychopathic disorder or central nervous system damage. 8.Continuous systemic administration(iv or po) of steroid. 9.Pregnancy, breast-feeding, possible pregnancy, and willing to be pregnant. 10.Particpation for other studies. 11.Impossible of oral ingestion. 12.Judged ineligible by the principal investigator of sub-investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Tsuchiya
Organization	Sendai City Medical Center Sendai Open Hospital
Division name	Director, GI Surgery
Address	5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL	022-252-1111
Email	tsuchiya@openhp.or.jp

Public contact
Name of contact person	Takashi Tsuchiya
Organization	Sendai City Medical Center Sendai Open Hospital
Division name	Director, GI Surgery
Address	5-22-1 Tsurugaya , Miyagino-ku, Sendai City, Miyagi
TEL	022-252-1111
Homepage URL
Email	tsuchiya@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center Sendai Open Hospital
Institute
Department

Funding Source
Organization	Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2016 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 10 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 05 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 28 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023981