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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002659
Receipt No. R000003237
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.
Date of disclosure of the study information 2009/11/01
Last modified on 2017/05/01

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Basic information
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
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
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

Public contact
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

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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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/ctr_e/ctr_view.cgi?recptno=R000003237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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