UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017882 |
|---|---|
| Receipt number | R000020717 |
| Scientific Title | Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT Non-synbiotics vs synbiotics |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2021/12/10 15:25:46 |
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Basic information
Public title
Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT
Non-synbiotics vs synbiotics
Acronym
Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT
Non-synbiotics vs synbiotics
Scientific Title
Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT
Non-synbiotics vs synbiotics
Scientific Title:Acronym
Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT
Non-synbiotics vs synbiotics
Region
| Japan |
Condition
Condition
malignant lymphoma
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 Gfine 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
Duration of TPN
Key secondary outcomes
(1) Diarrhea and infectious diseases
(2) Regimen related toxicity except diarrhea and infectious diseases
(3) Engraftment
(4) Effect of appetite hormone
(5) Quality of life
(6) GLP-2 blood level
(7) Nutritional condition
(8) Length of stay and Cost-effectiveness
(9) Period of failure to TPN administer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Synbiotics: Use of Gfine in patients who receive autologous PBSCT
Interventions/Control_2
Placebo: Use of Placebo 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 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 Gfine
(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)
(9) Patients who do not ingest enough calories
(10) Investigator rejection
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Division name
Medical Oncology/Hematology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
0783825111
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Mizutani |
Organization
Kobe University Hospital
Division name
Medical Oncology/Hematology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
0783825111
Homepage URL
mizuyu@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Medical Oncology/Hematology, Department of Medicine
Kobe University Hospital and Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Clinical Research Ethical Committee
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe city, Hyogo Prefecture, JAPAN, 650-0017
Tel
078-382-6669
cerb@med.kobe-u.ac.jp
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
| 2015 | Year | 06 | Month | 12 | 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
12
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
| 2015 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 09 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 04 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 04 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020717
