UMIN-CTR Clinical Trial

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
Email	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
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	Institutional Review Board of Aizawa Hospital
Address	2-5-1 Honjou Matsumoto, Nagano 390-8510 Japan
Tel	0263-33-8600
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039187