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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033613
Receipt No. R000038333
Official scientific title of the study 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 2018/08/02

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Basic information
Official scientific title of the study Randomized controlled trials on prevention of sarcopenia during gastric cancer surgery by exercise and nutrition intervention
Title of the study (Brief title) 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 Susumu Aikou
Organization The University of Tokyo
Division name Department of Bariatric & Metaboric Care
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email aikous-tky@umin.ac.jp

Public contact
Name of contact person Susumu Aikou
Organization The University of Tokyo
Division name Department of Bariatric & Metaboric Care
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 13 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 02 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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