UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024526 |
|---|---|
| Receipt number | 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 | 2021/04/28 10:48:04 |
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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
rakugi@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Akasaka |
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
akasaka@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Geriatric and General Medicine, Gastroenterological surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2024 | 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
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028234
