UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028575 |
|---|---|
| Receipt number | R000032705 |
| Scientific Title | Examination of the effect of long-term exercise and nutritional therapy after hepatectomy on sarcopenia and prognosis |
| Date of disclosure of the study information | 2017/08/08 |
| Last modified on | 2022/08/12 12:00:22 |
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Basic information
Public title
Examination of the effect of long-term exercise and nutritional therapy after hepatectomy on sarcopenia and prognosis
Acronym
Examination of the effect of long-term exercise and nutritional therapy after hepatectomy on sarcopenia and prognosis
Scientific Title
Examination of the effect of long-term exercise and nutritional therapy after hepatectomy on sarcopenia and prognosis
Scientific Title:Acronym
Examination of the effect of long-term exercise and nutritional therapy after hepatectomy on sarcopenia and prognosis
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether nutritional and exercise support for patients after hepatic resection of hepatocellular carcinoma contribute to muscle mass volume and prognosis or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate of muscle mass volume at the first year after hepatectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Exercise and nutritional support every 3 months after surgery
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient diagnosed as hepatocellular carcinoma.
Patient who is possible to perform hepatectomy.
Patient who is under Performance Status (PS) 1.
Patients who had consent.
Key exclusion criteria
Patients who need exercise restriction due to severe heart disease, respiratory disease, etc.
Patients who require dietary restrictions such as inflammatory bowel disease.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Iida |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Tsukinowa-cho, Seta, Otsu, Shiga
TEL
077-548-2238
hiroya@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Iida |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Tsukinowa-cho, Seta, Otsu, Shiga
TEL
077-548-2238
Homepage URL
hiroya@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
NA
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
Ethical Review Board of Shiga University of Medical Science
Address
Tsukinowa-cho, Seta, Otsu, Shiga
Tel
077-548-3619
hesafem@belle.shiga-med.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 08 | 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
50
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032705
