UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000034323