UMIN-CTR Clinical Trial

Public title

Prospective exploratory study for evaluating the efficacy of taking ENEVO long term for gastric
cancer patients after gastrectomy.

Acronym

Prospective exploratory study for evaluating the efficacy of taking ENEVO long term for gastric
cancer patients after gastrectomy.

Scientific Title

Prospective exploratory study for evaluating the efficacy of taking ENEVO long term for gastric
cancer patients after gastrectomy.

Scientific Title:Acronym

Prospective exploratory study for evaluating the efficacy of taking ENEVO long term for gastric
cancer patients after gastrectomy.

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

There are many reports that body weight loss after gastrectomy cause lower completion rate of adjuvant chemotherapy. So it is suggested there is a need for nutrition intervention for gastric cancer patients after surgery.
We will evaluate the efficacy of oral nutritional supplements using ENEVO to the gastric cancer patients after gastrectomy. And We will evaluate the efficacy of taking ENEVO everyday long term.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

The body weight loss rate as compared to preoperative body weight at 24weeks after beginning to take ENEVO.

Key secondary outcomes

1.The body weight loss rate as compared to preoperative body weight at 52weeks after beginning to take ENEVO .
2.The maximum body weight loss rate as compared to preoperative body weight.
3.Nutritional assessment.
4.Incidence of adverse events.
5.In case of adjuvant chemotherapy,treatment completion rate.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ENEVO administration for 24weeks

Interventions/Control_2

ENEVO administration for 2weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)The patient who diagnosed with histologically gastric cancer.
2)The patient who is more than 20 years old to below 75 years old.
3)The patient who received no existing treatment(including neoadjuvant chemotherapy) and are scheduled surgery in primary resection.
4)The patient who is PS(ECOG) from 0-2.
5)The patient who can be oral ingestion.
6)The patient who can obtain informed consent.
7)The patient who can write a diary exactly.

Key exclusion criteria

1)The patient who are overlapped cancer of synchronism or metachronous, or who are multiple cancer.
2)The patient who contraindicated of ENEVO.
3)The patient who are participating in other clinical trials.
4)The patient who is not suitable for this clinical study by researchers.
5)The patient who experienced severe postoperative complications(more than Grade3 of Clavien-Dindo classification).

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Shigeki Yamada

Organization

Fujita Health University

Division name

Department of clinical pharmacy

Zip code

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

TEL

0562-93-2111

Email

syamada@fujita-hu.ac.jp

Name of contact person

1st name
Middle name
Last name	Miyuki Ueno

Organization

Fujita Health University

Division name

Department of clinical pharmacy

Zip code

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan

TEL

0562-93-2111

Homepage URL

Email

miyukioya28@gmail.com

Institute

Fujita Health University Hospital

Institute

Department

Personal name

Organization

Fujita Health University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

11

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

16

Day

Last modified on

2017

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020661