UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043108 |
|---|---|
| Receipt number | R000049210 |
| Scientific Title | Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2021/01/23 19:52:48 |
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Basic information
Public title
Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Acronym
Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Scientific Title
Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Scientific Title:Acronym
Clinical study of preoperative nutrition counseling and exerecise guidance for frail patients with upper gastrointestinal cancers
Region
| Japan |
Condition
Condition
upper gastrointestinal tract cancers
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of preoperative nutritional counseling and exercise guidance for frail patients with upper gastrointestinal tract cancers aiming to keep their body weight and improve their Nutritional status postoperatively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of weight loss at six months after surgery
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
| Behavior,custom | Other |
Interventions/Control_1
nutritional counseling
exercise guidance
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are going to undergo on operation for upper gastrointestinal tract cancers at Kansai Rosai Hospital
2)Patients who agree in writing
Key exclusion criteria
1) Patients who are difficult to understand the meaning of the counseling
2) Patients who are judged to be unsuitable by the attending physicians
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | ATSUSHI |
| Middle name | |
| Last name | TAKENO |
Organization
Kansai Rosai Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
6608511
Address
3-1-69, Inabasou, Amagasaki, Hyogo
TEL
06-6416-1221
takeno-atsushi@kansaih.johas.go.jp
Public contact
Name of contact person
| 1st name | ATSUSHI |
| Middle name | |
| Last name | TAKENO |
Organization
Kansai Rosai Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
6608511
Address
3-1-69, Inabasou, Amagasaki, Hyogo
TEL
06-6416-1221
Homepage URL
takeno-atsushi@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Rosai Hospital
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
Kansai Rosai Hospital
Address
3-1-69, Inabasou, Amagasaki, Hyogo
Tel
06-6416-1121
takeno-atsushi@kansaih.johas.go.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
| 2021 | Year | 01 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2021 | Year | 01 | Month | 23 | Day |
Last modified on
| 2021 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049210
