UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027056 |
|---|---|
| Receipt number | R000031015 |
| Scientific Title | The effect of amino acid administration on the reduction of muscle mass in patients undergoing gastrectomy |
| Date of disclosure of the study information | 2017/04/19 |
| Last modified on | 2020/04/20 23:14:53 |
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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
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
sur148@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college, General and Gastroenterological Surgery
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031015
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