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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024526
Receipt No. R000028234
Scientific Title A randomized trial for the beneficial effect of pre-operative intervention on physical frailty as a poor prognostic factor after surgery for gastrointestinal cancer in older adults
Date of disclosure of the study information 2016/12/01
Last modified on 2019/10/27

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Basic information
Public title A randomized trial for the beneficial effect of pre-operative intervention on physical frailty as a poor prognostic factor after surgery for gastrointestinal cancer in older adults
Acronym A trial for the beneficial effect of pre-operative intervention in older adults with gastrointestinal cancer
Scientific Title A randomized trial for the beneficial effect of pre-operative intervention on physical frailty as a poor prognostic factor after surgery for gastrointestinal cancer in older adults
Scientific Title:Acronym A trial for the beneficial effect of pre-operative intervention in older adults with gastrointestinal cancer
Region
Japan

Condition
Condition gastrointestinal cancer
Classification by specialty
Geriatrics Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the beneficial effects of pre-operative intervention on physical frailty (physical training and nutritional replenishment) for the older adults (70 years of age or older) with physical frailty expecting to undergo gastrointestinal surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes postoperative complications
Key secondary outcomes 1) prognosis 1 year after surgery
2) changes of values of comprehensive geriatric assessment (CGA)
3) changes of body composition
4) changes of physical functions
5) changes of several biochemical tests
6) changes of serum concentrations of myokines and vitamin D

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Intervention Group:intervention with physical training and amino acids replenishment
Interventions/Control_2 Control group:without intervention
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) the ambulatory patients aged 70 years or older in Osaka University Hospital expecting to undergo digestive operations for gastrointestinal cancers (e.g. stomach/duodenum, esophagus, colorectal, hepatic, gallbladder, bile duct, and pancreas) within stage 3
2) the subjects diagnosed as physical frailty (decline of grip strength and/or gait speed)
Key exclusion criteria 1) the subjects with effort angina, chronic heart failure and tachyarrhythmia
2) the subjects with chronic respiratory failure
3) the subjects with active multiple cancers
4) the subjects who undergo preoperative chemotherapy
5) the subjects not able to walk by themselves
6) the subjects with chronic kidney disease
7) the subjects with severe hepatic dysfunction
8) the subjects with cognitive impairment
9) the subjects participating other clinical investigations
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Rakugi
Organization Osaka University Graduate School of Medicine
Division name Geriatric and General Medicine
Zip code 565-0871
Address 2-2, Yamada-oka, Suita, Osaka
TEL 06-6879-3852
Email rakugi@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Sugimoto
Organization Osaka University Graduate School of Medicine
Division name Osaka University Graduate School of Medicine
Zip code 5465-0871
Address 2-2, Yamada-oka, Suita, Osaka
TEL 06-6879-3852
Homepage URL
Email sugimoto@geriat.med.osaka-u.ac.jp

Sponsor
Institute Geriatric and General Medicine, Gastroenterological surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Geriatric and General Medicine, Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Center for Translational Research Osaka University Hospital
Address 2-2, Yamada-oka, Suita, Osaka, Japan
Tel rinri@hp-crc.med.osaka-u.ac.jp
Email rinri@hp-crc.med.osaka-u.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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 13 Day
Date of IRB
2016 Year 11 Month 16 Day
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
2021 Year 03 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
2016 Year 10 Month 23 Day
Last modified on
2019 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028234

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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