UMIN-CTR Clinical Trial

Basic information
Public title	Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Acronym	Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Scientific Title	Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Scientific Title:Acronym	Study of long-run effect of early nutritional intervention with an elemental diet (ELEMENTAL) for gastric cancer patients after surgical treatment as an accompanying research of KSES001.
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The study is performed to examine the inhibiting effect of weight loss after one year from the early nutritional intervention with an elemental diet by study of KSES001 and these patients are randomly assigned to ED group or control group. UMIN000008056
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of body weight loss from before the surgery to half a year and one year after the surgery, respectively.
Key secondary outcomes	(1) Area of skeletal muscle, maximum area of psoas major muscle, capacity of psoas major muscle, rate of skeletal muscle mass (corrected value) (2) Implementation status of the adjuvant chemotherapy (3) Period of duration after the adjuvant chemotherapy (4) Laboratory values (5) Existence or non-existence of relapse (6) Intake of elemental diet, oligomeric formula and polymeric formula (7) Late complications after surgery

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patients registered as key inclusion criteria of KSES001. Concretely, cases registered as KSES001 among those of the non-preoperative therapy and Gastric cancer those with Stage I, II or III undergo R0 surgery (TG surgery or DG surgery) from September, 2011 to June, 2012.
Key exclusion criteria	There is none of new key exclusion criteria because the patients of KSES001 are selected in this study.
Target sample size	108

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yutaka Kimura
Organization	Kindai University
Division name	Surgery
Zip code
Address	377-2,Oonohigashi, Osakasayama-shi, Osaka
TEL	072-366-0221
Email	you-kimura@surg.med-kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yutaka Kimura
Organization	Kindai University
Division name	Surgery
Zip code
Address	377-2,Oonohigashi, Osakasayama-shi, Osaka
TEL	072-366-0221
Homepage URL
Email	you-kimura@surg.med-kindai.ac.jp

Sponsor
Institute	KSES
Institute
Department

Funding Source
Organization	EA Pharma Co., Ltd.
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
Address
Tel
Email

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	2016 Year 08 Month 04 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	Completed
Date of protocol fixation	2016 Year 03 Month 05 Day
Date of IRB	2012 Year 02 Month 02 Day
Anticipated trial start date	2016 Year 03 Month 05 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter observational study

Management information
Registered date	2016 Year 08 Month 03 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027026