UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037122 |
|---|---|
| Receipt number | 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 13:21:25 |
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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
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
s-maeda@sakai-hospital.jp
Sponsor or person
Institute
Sakai City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
