UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001189 |
|---|---|
| Receipt number | R000001222 |
| Scientific Title | A multi-center randomized phase II study of nutritonal support with intensive glucose control after allogeneic stem cell transplantation lipid-free vs lipid |
| Date of disclosure of the study information | 2008/06/16 |
| Last modified on | 2017/09/12 17:49:15 |
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Basic information
Public title
A multi-center randomized phase II study of nutritonal support with intensive glucose control after allogeneic stem cell transplantation lipid-free vs lipid
Acronym
NST01
Scientific Title
A multi-center randomized phase II study of nutritonal support with intensive glucose control after allogeneic stem cell transplantation lipid-free vs lipid
Scientific Title:Acronym
NST01
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness and safety of fat emulsions with intensive glucose control in patients who received allogeneic stem cell transplantation (SCT) with myeloablative conditioning regimen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Documented infections at 100 days post-transplant
Key secondary outcomes
secondary endpoint
1.Overall survival and progression-free survival at 100 days post-transplant
2.Overall survival and progression-free survival at 1 year post-trasnplant
3.treatment-related toxicity(CTCAE ver.3.0)
4.probability and severity of GVHD
5.time to GVHD
6.time to engraftment
7.probability of engraftment
8.insulin dose
9.hyperglycemia and hypoglycemia(CTCAE ver.3.0)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Intensive Glucose control
Interventions/Control_2
Use of intravenous lipid formulation
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hematological malignancies who will benefit from allogeneic stem cell transplantation with myeloablative conditioining regimen
Key exclusion criteria
(1) CML blast crisis
(2) chemotherapy-refractory ML or ATLL
(3) Patient who has already received multiple allogeneic stem cell transplantation
(4) Patient with active infection
(5) Patient with uncontrolled CNS invasion
(6) Hypertriglyceridemia (>350 mg/dL)
(7) Patient with DM and with insulin therapy
(8) Patient who are pregnant
(9) Patient with mental disorder
(10) Patient with allergy to drugs which are included in conditioning regimen or GVHD prophylaxis
(11) Patient with allergy to intravenous lipid formulation or insulin
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sung-Won Kim |
Organization
National Cancer Center Hospital
Division name
Hematology and Stem Cell Transplantation
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
skim@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinobu Saito |
Organization
National Cancer Center Hospital
Division name
Data Center
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
shsaito@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2008 | Year | 06 | Month | 16 | 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
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
| 2007 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 13 | Day |
Last modified on
| 2017 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001222
| Research Plan | |
|---|---|
| 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 |
