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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004650
Receipt No. R000005541
Scientific Title Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Date of disclosure of the study information 2010/12/01
Last modified on 2014/08/29

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Basic information
Public title Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Acronym Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Scientific Title Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Scientific Title:Acronym Evaluation of Usefulness of ONS (Oral Nutritional Supplement) in Postoperative Patients with Gastric Cancer
Region
Japan Asia(except Japan)

Condition
Condition gastric cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine whether ONS is of clinical significance (effect to general condition) in patients for whom total gastrectomy and distal gastrectomy for cancer is indicated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percent change and amount of change in body weight (amount of change in BMI)
Key secondary outcomes 1)Percent change and amount of change in grip strength
2)QOL (EORTC QLQ-C30)
3)Percentage of completed chemotherapy (only patients receiving chemotherapy)
4)Nutritional indexes
5)Body composition
6)Occurrence of adverse events of ONS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Postoperatively, intervention with ONS at a dose of approximately 400 kcal/day will be administered and observed from the start of meal to 12 weeks after discharge.
Interventions/Control_2 We assess a control group in the same way for 12 weeks.
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 1)Male or female patients aged 20 years and older at the time of informed consent
2)Patients who are able to take orally
3)Patients who will receive radical total gastrectomy for cancer irrespective of technique
4) Patients who will receive radical distal gastrectomy for cancer irrespective of technique
4)Patients who have not received pretreatment for gastric cancer (radiation, chemotherapy, and hormonal therapy etc.)
5)Patients who fully understand the study procedures and have given voluntary written informed consent after a full explanation is given
Key exclusion criteria 1)Patients with ileus
2)Patients with no residual intestinal function
3)Patients with severe liver disorder
AST (GOT) or ALT (GPT) &#8805; 2.5 times the upper limit of normal at hospital
4)Patients with severe renal disorder
Cr &#8805; 2.0 mg/dL
5)Patients with abnormal glucose metabolism such as severe diabetes mellitus : HbA1c &#8805; 7.0%
6)Patients with allergy to any ingredient of milk, wheat, soy bean, or salmon
7)Pregnant women, women suspected of being pregnant, or lactating women
8)Patients with active double cancer and/or multiple cancer
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SETO, Yasuyuki
Organization THE UNIVERSITOY OF TOKYO
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name HATAO, Fumihiko
Organization THE UNIVERSITOY OF TOKYO
Division name Department of Gastrointestinal Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email fchobi@gmail.com

Sponsor
Institute THE UNIVERSITOY OF TOKYO
Institute
Department

Funding Source
Organization EN Otsuka Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
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
2010 Year 12 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 Completed
Date of protocol fixation
2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 01 Day
Last modified on
2014 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005541

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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