UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Harushi Osugi
Organization	Osaka City University Graduate School of medicine
Division name	Department of Gastroenterological Surgery
Address	1-4-3 , Asahimachi , Abeno-ku , Osaka city , 545-8585 JAPAN
TEL	06-6645-3841
Email	m9940141@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person	Yasunori Matsuda
Organization	Osaka City University Graduate School of medicine
Division name	Department of Gastroenterological Surgery
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

Sponsor
Institute	Osaka City University Hospital, Second Department of Surgery
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪市立大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2009 Year 11 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://link.springer.com/article/10.1007%2Fs00268-017-3893-y
Results
Other related information

Management information
Registered date	2009 Year 10 Month 22 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003237