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

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 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

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

Value
https://center6.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