UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Kentaro Kurashina
Organization	Jichi Medical University Hospital
Division name	Department of Surgery
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	Kentaro Kurashina
Organization	Jichi Medical University Hospital
Division name	Department of Surgery
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

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011895