UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001339 |
|---|---|
| Receipt number | R000001626 |
| Scientific Title | Prospective randomized Phase II trial in nutritional support for autologous PBSCT Non-synbiotics vs Synbiotics |
| Date of disclosure of the study information | 2008/08/29 |
| Last modified on | 2014/01/20 09:51:26 |
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Basic information
Public title
Prospective randomized Phase II trial in nutritional support for autologous PBSCT
Non-synbiotics vs Synbiotics
Acronym
NST02
Scientific Title
Prospective randomized Phase II trial in nutritional support for autologous PBSCT
Non-synbiotics vs Synbiotics
Scientific Title:Acronym
NST02
Region
| Japan |
Condition
Condition
malignant lymphoma or multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety to use GFO and lactobacilus in patients who receive autologous PBSCT
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Probability of more than grade 3 intestinal regimen related toxicity
Key secondary outcomes
(1) 1-year overall survival and event-free survival
(2) Regimen related toxicity except intestinal toxicity
(3) Engraftment
(4) Infectious diseases
(5) Duration of TPN
(6) Dose and duration of intravenous morphine
(7) Dose of insulin
(8) Hyperglycemia and hypoglycemia
(9) DAO activity
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intervention: Use of GFO and lactobacillus in patients who receive autologous PBSCT
Interventions/Control_2
Standard : No Use of GFO and lactobacillus in patients who receive autologous PBSCT
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Malignant lymphoma or multiple myeloma who can be candidate for autologous PBSCT
(2) 17<Age<66
(3) ECOG PS <2
(4) No obvious organ failure
(5) They have given written informed consent
(6) Patients who will survive more than 3 months
Key exclusion criteria
(1) History of stem cell transplantation
(2) HIV carrier
(3) Uncontrolled active infectious diseases
(4) Pregnant or lactating
(5) Uncontrolled psychological disorder(6) Allergy for the drugs used for the conditioning regimen
(7) Allergy for GFO or lactobacillus
(8) Patients who do not tolerate the maximal defined conditioning regimen due to organ dysfunction (e.g., reduce MCNU due to pulmonary dysfunction, reduce Carboplatin due to renal dysfunction)
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
Hematology and Stem Cell Transplantation
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-3542-2511
skim@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Fuji |
Organization
NTT West Japan Osaka Hospital
Division name
Department of Hematology
Zip code
Address
2-6-40, Karasugatsuji, Tennoji-ku, Osaka-city, Osaka, 543-8922, Japan
TEL
0667737111
Homepage URL
http://www.ncc.go.jp/jp/
s-fuji@pj8.so-net.ne.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
the 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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 29 | 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
| 2008 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | 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
| 2008 | Year | 08 | Month | 29 | 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=R000001626
