UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018441 |
|---|---|
| Receipt number | R000021350 |
| Scientific Title | A single-arm study on the effectiveness of nutritional supplements containing amino acids for chemotherapy-induced mucositis. |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/07/28 19:02:06 |
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Basic information
Public title
A single-arm study on the effectiveness of nutritional supplements containing amino acids for chemotherapy-induced mucositis.
Acronym
A study of supplements containing amino acids for mucositis.
Scientific Title
A single-arm study on the effectiveness of nutritional supplements containing amino acids for chemotherapy-induced mucositis.
Scientific Title:Acronym
A study of supplements containing amino acids for mucositis.
Region
| Japan |
Condition
Condition
Patients with hematological malignancy and need hematopoietic 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 the preventional effects of oral nutritional supplements containing amino acids for chemotherapy-induced mucositis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mucositis, diarrhea, and nausea was graded according to NCI-CTCAE 4.0 (at the point of discharge or two months from intervention)
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
To take nutritional supplements containing amino acids.
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 | Masafumi Taniwaki |
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
taniwaki@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 | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 29 | 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
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2017 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021350
