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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036022
Receipt No. R000040842
Scientific Title Effects of exercise therapy and protein supplementation on the early recovery of skeletal muscular volume in perioperative gastrointestinal cancer patient
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/27

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Basic information
Public title Effects of exercise therapy and protein supplementation on the early recovery of skeletal muscular volume in perioperative gastrointestinal cancer patient
Acronym Protein supplementation on perioperative exercise therapy
(Early Re-Instatement to work : ERI trial)
Scientific Title Effects of exercise therapy and protein supplementation on the early recovery of skeletal muscular volume in perioperative gastrointestinal cancer patient
Scientific Title:Acronym Protein supplementation on perioperative exercise therapy
(Early Re-Instatement to work : ERI trial)
Region
Japan

Condition
Condition Gastrointestinal cancer
Classification by specialty
Medicine in general Endocrinology and Metabolism Gastrointestinal surgery
Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the skeletal muscular volume and strength of the legs in gastrointestinal cancer patients with or without protein supplementation during perioperative exercise therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change rate of femoral skeletal muscular area at 9th week after discharge from hospital comparing before exercise and protein supplementation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 protein supplementation
Interventions/Control_2 placebo
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients who are diagnosed to need surgery with gastrointestinal cancer at Wakayama Rosai Hospital and give their concent
Key exclusion criteria Patients who are judged as unfit for exercise therapy by a rehabilitation doctor
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kishio Nanjo
Organization Wakayama Rosai Hospital
Division name Director
Zip code
Address 93-1 Kinomoto, Wakayama 640-8505 , Japan
TEL 073-451-3181
Email k-nanjo@wakayamah.johas.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhito Kobayashi
Organization Wakayama Rosai Hospital
Division name Deputy director
Zip code
Address 93-1 Kinomoto, Wakayama 640-8505 , Japan
TEL 073-451-3181
Homepage URL
Email ysh-kobayashi@wakayamah.johas.go.jp

Sponsor
Institute Japan Organization of Occupational Health and Safety
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization Japanese Governmental office
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 和歌山労災病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 18 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
2019 Year 02 Month 27 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040842

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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