UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008908 |
|---|---|
| Receipt number | R000010448 |
| Scientific Title | Study test for development of comprehensive improvement of QOL by ghrelin in cancer treatment-Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery- |
| Date of disclosure of the study information | 2012/09/25 |
| Last modified on | 2019/03/19 15:46:11 |
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Basic information
Public title
Study test for development of comprehensive improvement of QOL by ghrelin in cancer treatment-Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery-
Acronym
Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery
Scientific Title
Study test for development of comprehensive improvement of QOL by ghrelin in cancer treatment-Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery-
Scientific Title:Acronym
Phase I/II clinical trial regarding clinical effect by ghrelin administration in patients who undergo hepato-biliary-pancreas surgery
Region
| Japan |
Condition
Condition
Malignant tumor in hepato-biliary-pancreas
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Surgery in general | Gastrointestinal surgery | Laboratory medicine |
| Operative medicine | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of improvement of oral intake, nutritional status and QOL in the early and long-term period by synthetic ghrelin in patients with hepato-biliary-pancreas malignancies who underwent radical operations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Postoperative morbidity, Post-administration side effect of ghrelin
Key secondary outcomes
calorie intake after meal, nutritional assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prospective randomized, placebo-controlled clinical trial assigned a total of 40 patients with hepato-biliary-pancreas maligancies who undergo radical surgery, into either ghrelin (n=20) or placebo group (n=20). In ghrelin group, synthetic human ghrelin (3ug/kg) is intravenously injected twice daily for 7 days from the day of oral intake after surgery.
Interventions/Control_2
In placebo-control group, saline is intravenously injected twice daily for 7 days from the day of oral intake after surgery.
Interventions/Control_3
In all five patients with malnutritional status who undergo hepato-biliary-pancreas surgery over 6 months later,synthetic human ghrelin (3ug/kg) is intravenously injected twice daily for 7 days.
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.Informed consent and agreement by patient of enrolling the present study
2.Age between 20-80 years old
3.Radical surgery for hepato-biliary-pancreas malignancies is achieved.
4.Poorly oral intake and malnutrition at 6 months after operation for hepato-biliary-pancreas surgery
5. Oral intake possible
Key exclusion criteria
1.Existence of serious co-morbidity or active multiple cancer
2.Judged as inadequate by project owner
3.Existence of serious liver (AST, ALT over double of upper limit of normal range) and kidney (creatinine over 2.0mg/dl) dysfunctions
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nanashima |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Division of Surgical Oncology and Department of Surgery
Zip code
850-0015
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
TEL
+81-095-819-7304
a-nanasm@alpha.med.nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nanashima |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Division of Surgical Oncology and Department of Surgery
Zip code
850-0015
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
TEL
+81-095-819-7304
Homepage URL
a-nanasm@alpha.med.nagasaki-u.ac.jp
Sponsor or person
Institute
Division of Surgical Oncology and Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
3rd department of medicine, university of miyazaki
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Surgical Oncology and Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Address
1-7-1 Sakamoto, Nagasaki-shi
Tel
095-819-7304
a-nanasm@alpha.med.nagasaki-u.ac.jp
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
長崎大学病院（長崎市）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
Scheduled single arm blind test could not b e performed.
Results date posted
| 2019 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
university of miyazaki
National Cancer Institute East hospital
Tottori university
Participant flow
3 times of conference, annually
Adverse events
none
Outcome measures
contents of study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010448
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