UMIN-CTR Clinical Trial

Basic information
Public title	Perioperative oral administration of Cystine and Theanine enhances recovery after thoracoscopic esophagectomy
Acronym	Perioperative oral administration of Cystine and Theanine enhances recovery after thoracoscopic esophagectomy
Scientific Title	Perioperative oral administration of Cystine and Theanine enhances recovery after thoracoscopic esophagectomy
Scientific Title:Acronym	Perioperative oral administration of Cystine and Theanine enhances recovery after thoracoscopic esophagectomy
Region	Japan

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

Objectives
Narrative objectives1	To determine whether perioperative oral administration of Cystine and Theanine had a significant impact on perioperative outcomes after thoracoscopic esophagectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical activity measured by an activity monitor
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	administration of placebo 4 days before to 13 days after surgery
Interventions/Control_2	administration of Cystine and Theanine 4 days before to 13 days after surgery
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) Indication for thoracoscopic esophagectomy in a prone position (gastric conduit is selected for reconstruction) (2) clinical Stage I - III (without T4 disease) (3) Patients must be at a score level 0 - 1 of ECOG performance status (4) Written informed consent must be obtained from patients
Key exclusion criteria	(1) Active infection (2) Poorly controlled hypertension (3) Poorly controlled diabetes mellitus (4) Patients with severe underlying circulatory disease (5) Participate in other study (6) Inability to take food orally (7) Need for intravenous amino acid infusion
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Nakano
Organization	Tohoku University
Division name	Division of Advanced Surgical and Science and Technology
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7214
Email	torun@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Sakurai
Organization	Tohoku University
Division name	Division of Advanced Surgical and Science and Technology
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL	022-717-7214
Homepage URL
Email	tsakurai@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Division of Advanced Surgical and Science and Technology
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	Tohoku University
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel	022-717-7214
Email	tsakurai@med.tohoku.ac.jp

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 11 Month 16 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	40
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	2016 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2018 Year 11 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 15 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027891