UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019608 |
|---|---|
| Receipt number | R000022663 |
| Scientific Title | A single-arm study on the effects of providing information and guidance about nutritional supplements containing amino acids for the patients receiving hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2016/01/27 22:48:13 |
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Basic information
Public title
A single-arm study on the effects of providing information and guidance about nutritional supplements containing amino acids for the patients receiving hematopoietic stem cell transplantation.
Acronym
Effects of information and guidance about supplements containing amino acids for the patients receiving HSCT.
Scientific Title
A single-arm study on the effects of providing information and guidance about nutritional supplements containing amino acids for the patients receiving hematopoietic stem cell transplantation.
Scientific Title:Acronym
Effects of information and guidance about supplements containing amino acids for the patients receiving HSCT.
Region
| Japan |
Condition
Condition
Patients who are received hematopoietic stem cell transplantation (autologous or allogeneic)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether clinical benefits is obtained from providing clinical information about supplements containing amino acids for patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration and Amounts of taking supplements
Key secondary outcomes
grade of mucotitis, periods for opioids-use, fasting and discharge, change of body weight, laboratory data, overall survival, incidence of GVHD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Providing information and guidance about taking supplements containing amino acids (before therapy).
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients with hematological malignancy who need hematopoietic transplantation.
Key exclusion criteria
Patients who reject to participate in this trial, or who are in condition of being unable to make conscious judgment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Nisiuchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Nursing
Zip code
Address
465, Kajii-cho, Kamigyo-ku, Kyoto-city
TEL
075-251-5778
yukari-n@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Shimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Dept. of Hematology
Zip code
Address
465, Kajii-cho, Kamigyo-ku, Kyoto-city
TEL
075-251-5740
Homepage URL
http://www.f.kpu-m.ac.jp/k/hematol/
yshimura@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
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
| 2015 | Year | 11 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022663
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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