UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001925 |
|---|---|
| Receipt number | R000002341 |
| Scientific Title | Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study |
| Date of disclosure of the study information | 2009/05/01 |
| Last modified on | 2009/04/30 23:25:14 |
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Basic information
Public title
Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Acronym
Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Scientific Title
Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Scientific Title:Acronym
Effects of ghrelin administration after total gastrectomy in patients with gastric cancer: A prospective randomized placebo-controlled phase II study
Region
| Japan |
Condition
Condition
Gastric cancer patients who underwent total gastrectomy.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether exogenous ghrelin administration prevents postoperative body weight loss by improving appetite and oral food intake in patients with gastric cancer after undergoing total gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Food intake calories (during 10-days ghrelin administration)
Key secondary outcomes
appetite VAS, postoperative body weight, postoperative BMI (during 10-days ghrelin administration)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention A; ghrelin group (+)
ghrelin administration
postoperative 10-days
twice a day
before breakfast and before dinner
Interventions/Control_2
Intervention B; placebo group (-)
saline administration
postoperative 10-days
twice a day
before breakfast and before dinner
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
The inclusion criteria were as follows: 1) adenocarcinoma of the stomach confirmed by histopathological examination, 2) preoperative clinical staging with less than stage II (UICC TNM stage classification), 3) curative surgical treatment (R0), i.e., TG with D1 or D2 lymph node dissection, and 4) Age >20 and <80 years.
Key exclusion criteria
The exclusion criteria were the presence of any of the following; 1) cardiopulmonary, liver or renal dysfunction, 2) active dual malignancy, 3) pregnancy, 4) past history of gastrointestinal surgery, 5) postoperative complications after TG that could affect oral food intake, such as anastomotic leakage, pancreatitis and ileus.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
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
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
| 2009 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2005 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 30 | Day |
Last modified on
| 2009 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002341
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
