UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034374
Receipt No. 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 2019/04/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yasunori Nishida
Organization Aizawa Hospital
Division name Department of Surgery
Zip code
Address 2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
TEL 0263-33-8600
Email yasunori.198129@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Nishida
Organization Aizawa Hospital
Division name Department of Surgery
Zip code
Address 2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
TEL 0263-33-8600
Homepage URL
Email yasunori.198129@gmail.com

Sponsor
Institute Aizawa Hospital
Institute
Department

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
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 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.