UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study to explore the impact of the continuous individual nutritional counseling on the body weight loss in post-gastrectomy patients
Acronym	Evaluation of the efficacy of the continuous individual nutritional counseling in post-gastrectomy patients
Scientific Title	Prospective study to explore the impact of the continuous individual nutritional counseling on the body weight loss in post-gastrectomy patients
Scientific Title:Acronym	Evaluation of the efficacy of the continuous individual nutritional counseling in post-gastrectomy patients
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the impact of the continuos individual nutritional counseling on the body weight loss in post-gastrectomy patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Change of the body weight 12 months after gastrectomy
Key secondary outcomes	Association between the change of the body weight 12 months after gastrectomy and clinicopathological factors, change of the nutritional parameters 12 months after the gastrectomy, association between the change of the nutritional parameters 12 months after the gastrectomy and clinicopathological factors

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
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	Individual nutritional counseling
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 with histologically confirmed gastric cancer Patients in whom gastrectomy is planned Patients aged 20 years or older Patients with performance status of 0 or 1 Written informed consent
Key exclusion criteria	Patients with remnant gastric cancer Patients with R2 resection Patients in whom gastrectomy was not performed Patients in whom simultaneous surgery for another disease was performed Patients in whom treatment for another cancer is required Patients with duration of the postoperative hospital stay of 30 days or longer Patients with severe heart disease, respiratory disease, liver disfunction or renal disfunction Patients with uncontrolled diabetes mellitus Pregnant Patients with mental disorder
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Sohei Middle name Last name Matsumoto
Organization	Nara Medical University
Division name	Department of Surgery
Zip code	634-8522
Address	840 Shijo-cho, Kashihara, Nara, 634-8522, Japan
TEL	0744-22-3051
Email	msohei@naramed-u.ac.jp

Public contact
1st name of contact person	1st name Sohei Middle name Last name Matsumoto
Organization	Nara Medical University
Division name	Department of Surgery
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara, 634-8522, Japan
TEL	0744-22-3051
Homepage URL
Email	msohei@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University, Department of Surgery
Institute
Department

Funding Source
Organization	Self funding
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	Local Ethics Committee on Clinical Investigation of Nara Medical University
Address	840 Shijo-cho, Kashihara, Nara, 634-8522, Japan
Tel	0744-22-3051
Email	ino_rinri@naramed-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	奈良県立医科大学附属病院（奈良県）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 01 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	Preinitiation
Date of protocol fixation	2018 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 28 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036745