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

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 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


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

Value
https://center6.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