UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005039 |
|---|---|
| Receipt number | R000005978 |
| Scientific Title | Effects of ghrelin administration after esophagectomy in patients with esophageal cancer: phase II study |
| Date of disclosure of the study information | 2011/02/07 |
| Last modified on | 2015/12/14 00:16:28 |
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Basic information
Public title
Effects of ghrelin administration after esophagectomy in patients with esophageal cancer: phase II study
Acronym
Effects of ghrelin administration after esophagectomy in patients with esophageal cancer: phase II study
Scientific Title
Effects of ghrelin administration after esophagectomy in patients with esophageal cancer: phase II study
Scientific Title:Acronym
Effects of ghrelin administration after esophagectomy in patients with esophageal cancer: phase II study
Region
| Japan |
Condition
Condition
Esophageal cancer patients who underwent esophagectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of exogenous ghrelin administration for postoperative appetite and body weight loss in patients with esophageal cancer after undergoing esophagetomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Amount of food intake,postoperative body weight(during 10-days ghrelin administration)
Key secondary outcomes
Adverse events, appetite VAS, physiolosical examination, clinical blood examination (during 10-days ghrelin administration)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ghrelin administration
during 10-days
twice a day
before breakfast and before dinner
Interventions/Control_2
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) patients with esophageal cancer more than 1 year after esophagectomy
2) with curative surgical resection and without any recurrence
3) with more than 15% body weight loss compared to preoperative body weight or less than 19 of BMI
4) Age>20 and <80 years
5) oral intake possible
6) written informed consent
Key exclusion criteria
1) with severe complication or active dual malignancy
2) judged as inappropriate by physician-in-charge
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Takiguchi |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
Homepage URL
Sponsor or person
Institute
Osaka University School of Medicine Gastroenterological 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Exogenous administration of ghrelin improved appetite and oral food intake in patients who survived long-term after esophagectomy. Ghrelin administration may be an important therapy for improving the nutritional status of post-eosphagectomy patients.
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 06 | Day |
Last modified on
| 2015 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005978
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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