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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037122
Receipt No. R000042248
Scientific Title Exploratory research on the development of nutritional prehabilitation for sarcopenic patients in GI tract cancers
Date of disclosure of the study information 2019/06/21
Last modified on 2019/06/20

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Basic information
Public title Intervention study on the development of nutritional prehabilitation for sarcopenic patients in the GI tract cancers
Acronym Nutritional prehabilitation for sarcopenic patients
Scientific Title Exploratory research on the development of nutritional prehabilitation for sarcopenic patients in GI tract cancers
Scientific Title:Acronym Nutritional prehabilitation for sarcopenic patients
Region
Japan

Condition
Condition GI tract cancers
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate the clinical efficacy of our original home-based nutritional prehabilitation protocol for the sarcopenic patients in GI tract cancers during waiting time for surgery about its feasibility and usefulness in comparison with sarcopenic patgients without intervention.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skeletal muscle mass, grip strength, gait speed, knee extension strength, balance ability after intervention
Key secondary outcomes swallowing ability and QOL after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Home-based resistance training, swallowing exercise, nutritional counseling and protein supplementation for 3-4 weeks before surgery
Interventions/Control_2 Home-based resistance training during waiting period
Interventions/Control_3 Home-based swallowing exercise during waiting period
Interventions/Control_4 Nutritional counseling and protein supplementation
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
95 years-old >=
Gender Male and Female
Key inclusion criteria patients diagnosed according to the AWGS criteria who will receive curative surgery for GI tract cancer
Key exclusion criteria difficult to eat meals, motor dysfunction, severe organ failure
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Sakae
Middle name
Last name Maeda
Organization Sakai City Medical Center
Division name Dept. of Surgery
Zip code 593-8304
Address 1-1-1 Ebaraji-cho, Nishi-ku, Sakai City, Osaka
TEL 072-272-1199
Email s-maeda@sakai-hospital.jp

Public contact
Name of contact person
1st name Sakae
Middle name
Last name Maeda
Organization Sakai City Medical Center
Division name Dept. of Surgery
Zip code 593-8304
Address 1-1-1 Ebaraji-cho, Nishi-ku, Sakai City, Osaka
TEL 072-272-1199
Homepage URL
Email s-maeda@sakai-hospital.jp

Sponsor
Institute Sakai City Medical Center
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sakai City Medical Center
Address 1-1-1 Ebaraji-cho, Nishi-ku, Sakai City, Osaka
Tel 072-272-1199
Email s-maeda@sakai-hospital.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 21 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 19 Day
Date of IRB
2018 Year 12 Month 04 Day
Anticipated trial start date
2019 Year 02 Month 04 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
2019 Year 06 Month 20 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042248

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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