UMIN-CTR Clinical Trial

Public title

Evaluation of effects of enteral nutrient enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants in patients underwent radical surgery for thoracic esophageal cancer.

Acronym

Evaluation of effects of enteral nutrient enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants in patients underwent radical surgery for thoracic esophageal cancer.

Scientific Title

Evaluation of effects of enteral nutrient enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants in patients underwent radical surgery for thoracic esophageal cancer.

Scientific Title:Acronym

Evaluation of effects of enteral nutrient enriched with eicosapentaenoic acid (EPA), gamma-linolenic acid (GLA), and antioxidants in patients underwent radical surgery for thoracic esophageal cancer.

Region

Japan

Condition

Esophageal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the perioperative effects of enteral nutrient enriched with EPA, GLA, and antioxidants comparing with the existing enteral nutrient, in patients underwent radical surgery for thoracic esophageal cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II,III

Primary outcomes

improvement in oxygenation condition(PaO2/ FiO2 ratio)

Key secondary outcomes

acute inflammatory reaction
transition of maximum body temperature
body composition analysis
perioperative complication
length of post operative hospitalization

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Enteral formula enriched with EPA, GLA, and antioxidants (experimental diet)(PODs 2-8)

Interventions/Control_2

Isonitrogenous, isocaloric standard enteral formula (control diet)(PODs 2-8)

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patients underwent radical surgery for thoracic esophageal cancer along with 2 or 3-field lymphadenectomy
patients assessed to be able to consume enteral feeding from 2PODs by attending physician

Key exclusion criteria

Palliative and Emergency esophagectomy case
Patients with severe immunosuppression
Patients with cardiac, liver, or renal failure
Patients with abnormal amino acid metabolism
Known allergy of milk protein and lactose intolerance
Patients assessed to be unsuitable for inclusion the study or enteral feeding

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Harushi Osugi

Organization

Osaka City University Graduate School of medicine

Division name

Department of Gastroenterological Surgery

Zip code

Address

1-4-3 , Asahimachi , Abeno-ku , Osaka city , 545-8585 JAPAN

TEL

06-6645-3841

Email

m9940141@msic.med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasunori Matsuda

Organization

Osaka City University Graduate School of medicine

Division name

Department of Gastroenterological Surgery

Zip code

Address

1-4-3 , Asahimachi , Abeno-ku , Osaka city , 545-8585 JAPAN

TEL

06-6645-3841

Homepage URL

Email

m1293311@msic.med.osaka-cu.ac.jp

Institute

Osaka City University Hospital, Second Department of Surgery

Institute

Department

Personal name

Organization

none

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

大阪市立大学医学部附属病院（大阪府）

Date of disclosure of the study information

2009

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://link.springer.com/article/10.1007%2Fs00268-017-3893-y

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

Main results already published

Date of protocol fixation

2009

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

01

Day

Last follow-up date

2012

Year

10

Month

01

Day

Date of closure to data entry

2013

Year

01

Month

01

Day

Date trial data considered complete

2013

Year

01

Month

01

Day

Date analysis concluded

2013

Year

04

Month

01

Day

Other related information

Registered date

2009

Year

10

Month

22

Day

Last modified on

2017

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003237