UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024849 |
|---|---|
| Receipt number | 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 | 2020/12/07 08:47:07 |
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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 | 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
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
tsakurai@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Division of Advanced Surgical and Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027891
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
