UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034374 |
|---|---|
| Receipt number | R000039187 |
| Scientific Title | Effects of postoperative exercise therapy combined with branched-chain amino acid supplementation on body composition after gastrectomy in elderly patients |
| Date of disclosure of the study information | 2018/10/10 |
| Last modified on | 2022/10/06 10:47:19 |
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Basic information
Public title
Effects of postoperative exercise therapy combined with branched-chain amino acid supplementation on body composition after gastrectomy in elderly patients
Acronym
Effects of postoperative exercise therapy combined with BCAA on body composition after gastrectomy in elderly patients
Scientific Title
Effects of postoperative exercise therapy combined with branched-chain amino acid supplementation on body composition after gastrectomy in elderly patients
Scientific Title:Acronym
Effects of postoperative exercise therapy combined with BCAA on body composition after gastrectomy in elderly patients
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of postoperative exercise therapy combined with branched-chain amino acid supplementation on body composition after gastrectomy in elderly patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (skeletal muscle mass), hand grip strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral supplementation of 1 pack of branched-chain amino acid supplementation (REHADAYS) per day for 30 days from the 2nd day after surgery
Rehabilitation is carried out every day for 30 days from the next day after surgery
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients over 65 years of age who undergo open and laparoscopic gastrectomy (total gastrectomy and distal gastrectomy) with curative intent
(2) ECOG performance status score: 0-1
(3) Informed concent was obtained from the patient
Key exclusion criteria
(1) History of liver and renal dysfunction
(2) History of shock or hypersensitivity against this branched-chain amino acid supplementation.
(3) History of anticancer chemotherapy for gastric cancer preoperatively
(4) Patients who cannot undergo rehabilitation because of physical disability
(5) Any patients who was judged as inappropriate candidate to enroll this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Nishida |
Organization
Aizawa Hospital
Division name
Department of Surgery
Zip code
390-8510
Address
2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
TEL
0263-33-8600
yasunori.198129@gmail.com
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Nishida |
Organization
Aizawa Hospital
Division name
Department of Surgery
Zip code
390-8510
Address
2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
TEL
0263-33-8600
Homepage URL
yasunori.198129@gmail.com
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory 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
Institutional Review Board of Aizawa Hospital
Address
2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
Tel
0263-33-8600
kenkyu@ai-hosp.or.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
社会医療法人財団慈泉会 相澤病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 10 | 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
18
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039187
