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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024849
Receipt No. R000027891
Scientific Title Perioperative oral administration of Cystine and Theanine enhances recovery after thoracoscopic esophagectomy
Date of disclosure of the study information 2016/11/16
Last modified on 2019/05/21

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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
Middle name
Last name Nakano Toru
Organization Tohoku University
Division name Division of Advanced Surgical and Science and Technology
Zip code
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
Middle name
Last name Sakurai Tadashi
Organization Tohoku University
Division name Division of Advanced Surgical and Science and Technology
Zip code
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
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

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
2019 Year 05 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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