UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010568 |
|---|---|
| Receipt number | 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 10:58:02 |
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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
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
kurashonan@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011895
