UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003884 |
|---|---|
| Receipt number | R000004674 |
| Scientific Title | Multicenter clinical trial of nutritional Management in Reduced-Intensity Stem Cell Transplantation from An Unrelated Donor (with or without A Liquid Diet Containing Digested-form Oligopeptide) |
| Date of disclosure of the study information | 2010/07/07 |
| Last modified on | 2014/01/20 09:51:59 |
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Basic information
Public title
Multicenter clinical trial of nutritional Management in Reduced-Intensity Stem Cell Transplantation from An Unrelated Donor (with or without A Liquid Diet Containing Digested-form Oligopeptide)
Acronym
NST-04
Scientific Title
Multicenter clinical trial of nutritional Management in Reduced-Intensity Stem Cell Transplantation from An Unrelated Donor (with or without A Liquid Diet Containing Digested-form Oligopeptide)
Scientific Title:Acronym
NST-04
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of oligopeptide in patients who underwent unrelated stem cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Probability of more than grade 3 intestinal toxicity up to 28 days after transplant
Key secondary outcomes
(1) 1-year overall survival and 1-year progression-free survival
(2) Total duration of more than grade 3 intestinal toxicity up to 28 days
(3) Treatment-related toxicity
(4) Engraftment
(5) Acute GVHD
(6) Infection
(7) Duration of TPN
(8) Dose and duration of intravenous molphine
(9) Total dose of insulin
(10) Hyperglycemia and hypoglycemia
(11) DAO activity
(12) Laboratory data (total protein, albumin, cholinesterase, pre-albumin, RBP, CRP, urinary creatinine)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
| Food |
Interventions/Control_1
Patients will take oligopeptide from the beginning of conditioning regimen and up to 21 days after transplantation
Interventions/Control_2
Patients in non-oligopeptide group will not take oligopeptide
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patient with hematological malignancy which has the indication for the allogeneic transplant.
(2) Patient who receives an unrelated stem cell source
(3) Patient who can take oligopeptide
(4) Age from 18 to 70
(5) ECOG PS 0 or 1
(6) Patient who cannot tolerate myeloablative conditioning regimen
(7) Patient who had the informed consent
(8) Patient who expects to survive longer than 3 months
Key exclusion criteria
(1) Patient with severe organ dysfunction
(2) Patient with the postitivity of anti-HIV antibody
(3) Patient with uncontrolled infection
(4) Patient with pregnancy or breast feeding
(5) Patient with pshycological disease
(6) Patient with allergy against the drugs which are used for allogeneic transplant including chemotherapy and GVHD prophylaxis
(7) Patient with allergy against oligopeptide
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sung-Won Kim |
Organization
National Cancer Center Hospital
Division name
Department of hematology
Zip code
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo
TEL
+81-3-3542-2511
skim@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sung-Won Kim |
Organization
National Cancer Center Hospital
Division name
Department of hematology
Zip code
Address
5-1-1, Tsukiji, Chuo-Ku, Tokyo
TEL
+81-3-3542-2511
Homepage URL
skim@ncc.go.jp
Sponsor or person
Institute
Research supported by Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
国立がんセンター中央病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 07 | Day |
Last modified on
| 2014 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004674
