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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001189
Receipt No. 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

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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
Email 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
Email shsaito@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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