UMIN-CTR Clinical Trial

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
Email	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
Email	aikous-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038333