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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003884
Receipt No. 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

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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
Email 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
Email skim@ncc.go.jp

Sponsor
Institute Research supported by Ministry of Health, Labour and Welfare
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004674

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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