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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016831
Receipt No. 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

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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
Email 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
Email morishita-ygc@umin.ac.jp

Sponsor
Institute Anjo Kosei Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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