UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033613 |
|---|---|
| Receipt number | R000038333 |
| Scientific Title | Randomized controlled trials on prevention of sarcopenia during gastric cancer surgery by exercise and nutrition intervention |
| Date of disclosure of the study information | 2018/08/02 |
| Last modified on | 2020/08/03 17:36:35 |
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Basic information
Public title
Randomized controlled trials on prevention of sarcopenia during gastric cancer surgery by exercise and nutrition intervention
Acronym
Randomized controlled trials on prevention of sarcopenia during gastric cancer surgery by exercise and nutrition intervention
Scientific Title
Randomized controlled trials on prevention of sarcopenia during gastric cancer surgery by exercise and nutrition intervention
Scientific Title:Acronym
Randomized controlled trials on prevention of sarcopenia during gastric cancer surgery by exercise and nutrition intervention
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verify the prevention effect of sarcopenia during gastric cancer surgery by exercise and nutrition intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of sarcopenia
Key secondary outcomes
Weight, skeletal muscle mass, perioperative complications, hematological nutritional indicators, duration of postoperative chemotherapy, QOL, exercise habits, physical fitness tests, blood hormone, immunity and inflammatory cytokines
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Treatment intervention group
Perioperative resistance training, amino acid intake from 3 weeks or more before surgery to 3 months after surgery
Interventions/Control_2
Standard treatment group
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo gastric cancer surgery
PS 0-2
Consent has been obtained
Key exclusion criteria
Patients take preoperative chemotherapy.
Exercise training is diagnosed as inappropriate by general condition.
Patients take warfarin.
The doctor in charge judged it to be inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Aikou |
Organization
The University of Tokyo
Division name
Department of Bariatric & Metaboric Care
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
aikous-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Aikou |
Organization
The University of Tokyo
Division name
Department of Bariatric & Metaboric Care
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
aikous-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
RIZAP Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 02 | 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
24
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 | 07 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038333
| 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 |
