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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027563
Receipt No. R000031473
Scientific Title Efficacy of resistant starch and dietary supplement in hematopoietic stem cell transplant recipients
Date of disclosure of the study information 2017/06/19
Last modified on 2018/12/07

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Basic information
Public title Efficacy of resistant starch and dietary supplement in hematopoietic stem cell transplant recipients
Acronym RS study in HSCT
Scientific Title Efficacy of resistant starch and dietary supplement in hematopoietic stem cell transplant recipients
Scientific Title:Acronym RS study in HSCT
Region
Japan

Condition
Condition Hematopoietic stem cell transplant recipients
Classification by specialty
Hematology and clinical oncology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether the combination of resistant starch-rich diet and nutritional supplement
including oligosaccharides and dietary fibers, can reduce mucositis or gastrointestinal graft-versus-host disease (GVHD) in HSCT recipients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence and duration of severe (grade 3 or more) mucositis
Key secondary outcomes 1) Cumulative incidence of gastrointestinal acute GVHD
2) Duration of total parenteral nutrition

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 Start RS-rich diet and dietary supplement at the initiation of conditioning regimen, continuing through day +28.
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 1) HSCT recipients.
2) Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria 1) Subjects who are at risk of aspiration.
2) Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiko Shiraishi
Organization Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Division name Nutrition department
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL +81-3-3823-2101
Email y-shiraishi@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Kakihana
Organization Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Division name Hematology division
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL +81-3-3823-2101
Homepage URL
Email kakihana@cick.jp

Sponsor
Institute Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Institute
Department

Funding Source
Organization Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
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
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
2017 Year 06 Month 19 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 Main results already published
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 19 Day
Last follow-up date
2018 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031473

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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