UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027563 |
|---|---|
| Receipt number | 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 | 2020/04/15 16:27:33 |
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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 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) Subjects who are prohibited from eating for any reason.
3) Subject who have an allergy to provided prebiotics.
4) Subjects who are diagnosed with ileus.
5) 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 | Yukiko |
| Middle name | |
| Last name | Shiraishi |
Organization
Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Division name
Nutrition department
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
+81-3-3823-2101
kakihana@cick.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Kakihana |
Organization
Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Division name
Hematology division
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
TEL
+81-3-3823-2101
Homepage URL
kakihana@cick.jp
Sponsor or person
Institute
Tokyo metropolitan Cancer and Infectious diseases Center, Komagome hospital
Institute
Department
Personal name
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
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan
Tel
03-3823-2101
rinri@cick.jp
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
| 2020 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031473
