UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016831 |
|---|---|
| Receipt number | R000019533 |
| Scientific Title | The efficacy of an oral elemental diet in patients undergoing hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2015/03/18 |
| Last modified on | 2015/03/18 01:12:12 |
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Basic information
Public title
The efficacy of an oral elemental diet in patients undergoing hematopoietic stem cell transplantation
Acronym
The efficacy of an oral elemental diet for HSCT patients
Scientific Title
The efficacy of an oral elemental diet in patients undergoing hematopoietic stem cell transplantation
Scientific Title:Acronym
The efficacy of an oral elemental diet for HSCT patients
Region
| Japan |
Condition
Condition
Patients who undergone hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study was designed as a prospective cohort study. We administered oral elemental diet to successive patients.We examined of elemental diet by analyzing the difference of oral mucositis between the two groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We examined of elemental diet by analyzing the difference of hospitalization duration between the two groups.
Key secondary outcomes
We examined of short-term transplant outcome between the two groups.
Base
Study type
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
elemental diet
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergone HSCT
Key exclusion criteria
Patients who aren't in agreement to this study.Patients who dont undergo HSCT.Patient who can't administer elemental diet on tranplant date.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Sawa |
Organization
Anjo Kosei Hospital
Division name
Hematology and Oncology
Zip code
Address
28 Higashi-hirokute Anjo-cyo Anjo-city, Aichi, Japan
TEL
+81-566-75-2111
msawa@wine.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanobu Morishita |
Organization
Anjo Kosei Hospital
Division name
Hematology and Oncology
Zip code
Address
28 Higashi-hirokute Anjo-cyo Anjo-city, Aichi, Japan
TEL
+81-566-75-2111
Homepage URL
morishita-ygc@umin.ac.jp
Sponsor or person
Institute
Anjo Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Anjo Kosei Hospital
Organization
Division
Category of Funding Organization
Profit organization
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 | 03 | Month | 18 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 18 | Day |
Last modified on
| 2015 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019533
