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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010568
Receipt No. R000011895
Scientific Title Randomised clinical trial to evaluate postoperative quality of life and body weight loss with the use of EPA-enriched nutrient for resectable gastric cancer patients
Date of disclosure of the study information 2013/04/23
Last modified on 2016/10/25

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Basic information
Public title Randomised clinical trial to evaluate postoperative quality of life and body weight loss with the use of EPA-enriched nutrient for resectable gastric cancer patients
Acronym Postoperative QOL and body weight loss with perioperative Prosure administration for gastric cancer patients
Scientific Title Randomised clinical trial to evaluate postoperative quality of life and body weight loss with the use of EPA-enriched nutrient for resectable gastric cancer patients
Scientific Title:Acronym Postoperative QOL and body weight loss with perioperative Prosure administration for gastric cancer patients
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the degree of postoperative body weight loss and quality of life by the administration of Prosure for curatively resectable gastric cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Body weight loss and QOL score at 1/2/3/6 months after surgery
Key secondary outcomes postoperative functional disorder, lean body mass and skeletal muscle volume at 1/2/3/6 months after surgery, relative performance of Prosure, incidence of surgical morbidity.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 Oral supplimentation of 2 packs of Prosure per day for 7 days before surgery and 20 days after surgery.
Interventions/Control_2 Oral supplimentation of 1 pack of Prosure and 1 can of Ensure Liquid per day for 7 days before surgery and 20 days after surgery.
Interventions/Control_3 Oral supplimentation of 2 cans of Ensure Liquid per day for 7 days before surgery and 20 days after surgery.
Interventions/Control_4 No nutritional supplimentation given perioperatively.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. curative resection is possible by total gastrectomy or distal gastrectomy
2. not treated preoperative chemotherapy
3. age: 20-80 years
4. ECOG performance status: 0-1
5. sufficient organ functions
6. written informed consent
Key exclusion criteria 1. reduced oral intake
2. Treated with icosapentate ethyl
3. supplements containing eicosapentaenoic acid
4. synchronous or metachronous cancer
5. lactate intolerance or allergic reaction to milk/soy
6. hemorrhagic tendency
7. uncontrolled diabetes mellitus
8. Systemic treatment with corticosteroids
9. unstable angina or cardiac infarction within 6 months
10. pulmonary disease under oxygenation
11. Woman with ongoing pregnancy or breast-feeding, or contemplating pregnancy
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Kurashina
Organization Jichi Medical University Hospital
Division name Department of Surgery
Zip code
Address 3311-1, Yakushiji, Shimotsuke city, Tochigi, 329-0498, Japan
TEL 0285-58-7371
Email kurashonan@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Kurashina
Organization Jichi Medical University Hospital
Division name Department of Surgery
Zip code
Address 3311-1, Yakushiji, Shimotsuke city, Tochigi, 329-0498, Japan
TEL 0285-58-7371
Homepage URL
Email kurashonan@jichi.ac.jp

Sponsor
Institute Jichi Medical University Hospital
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2013 Year 04 Month 23 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 No longer recruiting
Date of protocol fixation
2013 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 23 Day
Last follow-up date
2014 Year 12 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
2013 Year 04 Month 23 Day
Last modified on
2016 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011895

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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