UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030061 |
|---|---|
| Receipt number | R000034323 |
| Scientific Title | Impact of preoperative exercise and nutritional therapy on the volume of visceral fat for obese gastric cancer patients |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2021/05/26 19:42:17 |
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Basic information
Public title
Impact of preoperative exercise and nutritional therapy on the volume of visceral fat for obese gastric cancer patients
Acronym
Impact of preoperative exercise and nutritional therapy on the volume of visceral fat for obese gastric cancer patients
Scientific Title
Impact of preoperative exercise and nutritional therapy on the volume of visceral fat for obese gastric cancer patients
Scientific Title:Acronym
Impact of preoperative exercise and nutritional therapy on the volume of visceral fat for obese gastric cancer patients
Region
| Japan |
Condition
Condition
obese patients with gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examin efficacy and safety of preoperative exercise and nutritional therapy for obese gastric cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
before-after ratio of visceral fat area
Key secondary outcomes
operation time
the volume of intraoperative bleeding
proportion of postoperative complications
duration of hospitalization
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 |
Interventions/Control_1
Exercise is walking more than 10000 steps/day.
Nutritional therapy is low carbon,high protein diets.Calorie restriction is not done.
Intervention term is about 4 weeks.
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
cStage I or II or III gastric cancer
visceral fat area is more than 100 square centimeter
Key exclusion criteria
ECOG PS 0 or 1
CHF(NYHA=2,3,4)
CRF(Hugh-Jones=2,3,4)
liver cirrhosis
CKD(eGFR<45ml/min/1.73m2)
gait disorder(can't walk 500m without rest)
Hb<9.0g/dl
Obstruction due to cancer
simultaneous surgery due to double cancer
neo-adjuvant chemotherapy
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Sakai |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
6068507
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
ysakai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Okada |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
6068507
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7595
Homepage URL
kokada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital, Department of Surgery
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
Kyoto university hospital ethics committe
Address
54, Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部付属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 15 | 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
18
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | 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 | 11 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034323
