UMIN-CTR Clinical Trial

Basic information
Public title	Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy
Acronym	Nutritional therapy to prevent dumping symptoms
Scientific Title	Intervention of personalized nutritional therapy to prevent dumping symptoms after gastrectomy
Scientific Title:Acronym	Nutritional therapy to prevent dumping symptoms
Region	Japan

Condition
Condition	Dumping symptoms after radical gastrectomy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of enteral nutrition to prevent dumping symptoms caused by blood glucose fluctuation after gastrectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Occurrence of dumping symptoms
Key secondary outcomes	Duration of hypoglycemia Fluctuations in blood glucose Compliance of enteral nutrition Incidence of adverse events Weight change Changes in nutritional indice Food intake

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	Treatment
Type of intervention	Food
Interventions/Control_1	Patients with dumping symptoms after distal gastrectomy wear a continuous blood glucose meter for 14 days. For 7 days, patients get enteral nutrition 200ml*2/day.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically diagnosed as gastric cancer 2) Radical resection was performed by distal gastrectomy (B-I reconstruction, RY reconstruction) 3) Three months or more after gastrectomy 4) Pathologically stageds as I or II 5) ECOG performance status score is 0-1 6) Able to fill out a questionnaire by themselves 7) Written informed consent
Key exclusion criteria	1) During chemotherapy (including postoperative adjuvant chemotherapy) 2) History of diabetes 3) Other enteral nutritional supplements and dietary supplements are used together 4) Some medical conditions that the investigator determines to be inappropriate.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Hiki
Organization	Kitasato University School of Medicine
Division name	Department of Upper Gastrointestinal Surgery
Zip code	2520203
Address	1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL	042-778-9974
Email	nhiki@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Ushiku
Organization	Kitasato University School of Medicine
Division name	Department of Upper Gastrointestinal Surgery
Zip code	2520203
Address	1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL	042-778-9974
Homepage URL
Email	bridle_leather_0514@hotmail.com

Sponsor
Institute	Kitasato University School
Institute
Department

Funding Source
Organization	Kitasato University School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Kitasato University School

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University School of Medicine and Hospital Ethics Committee
Address	1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
Tel	042-778-8273
Email	rinri-n@kitasato-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	北里大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 09 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
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	2020 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date	2020 Year 09 Month 15 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 12 Day
Last modified on	2020 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047262