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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030061
Receipt No. 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

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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
Email 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
Email kokada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital, Department of Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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