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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033548
Receipt No. R000036745
Scientific Title Prospective study to explore the impact of the continuous individual nutritional counseling on the body weight loss in post-gastrectomy patients
Date of disclosure of the study information 2018/08/01
Last modified on 2019/03/29

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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
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
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

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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