UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002659 |
|---|---|
| Receipt number | 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 17:42:20 |
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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
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
m1293311@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Hospital, Second Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003237
