UMIN-CTR Clinical Trial

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	2020 Year 03 Month 06 Day

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