UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018671 |
|---|---|
| Receipt number | R000021583 |
| Scientific Title | Prospective randomized trial of nutritional support for esophageal patients after esophagectomy |
| Date of disclosure of the study information | 2015/08/14 |
| Last modified on | 2016/08/14 13:19:00 |
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Basic information
Public title
Prospective randomized trial of nutritional support for esophageal patients after esophagectomy
Acronym
Nutritional support for esophageal patients after esophagectomy
Scientific Title
Prospective randomized trial of nutritional support for esophageal patients after esophagectomy
Scientific Title:Acronym
Nutritional support for esophageal patients after esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of Aband for body weight loss in esophageal cancer patients after esophagectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change of body weight 6 months after surgery
Key secondary outcomes
Change of body weight 12 months after surgery, change of body composition 6 and 12 months after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take Aband for 3 months after esophagectomy
Interventions/Control_2
No treatment
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Esophageal cancer patients underwent curative esophagectomy and reconstruction with stomach
2. Performance status 0-2
3. No serious abnormality in heart, lung, bone marrow, liver, and renal functions
Key exclusion criteria
1. Severe postoperative complications
2. Scheduled to receive postoperative adjuvant therapy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keijiro Sugimura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Surgery
Zip code
Address
1-3-3 Higashinari-ku, Osaka
TEL
06-6972-1181
sugimura-ke@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keijiro Sugimura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Surgery
Zip code
Address
1-3-3 Higashinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
sugimura-ke@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
大阪府立成人病センター
大阪府立急性期・総合医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 14 | Day |
Last modified on
| 2016 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021583
