UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052185 |
|---|---|
| Receipt number | R000056389 |
| Scientific Title | A prospective study on clinical indicators that affect the rate of weight loss in allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2023/09/12 |
| Last modified on | 2023/09/12 18:42:09 |
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Basic information
Public title
Single-center prospective pilot intervention study on clinical indicators influencing weight loss in allogeneic hematopoietic stem cell transplantation
Acronym
Prospective study on weight loss rate in allogeneic hematopoietic stem cell transplantation
Scientific Title
A prospective study on clinical indicators that affect the rate of weight loss in allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Prospective study on weight loss rate in allogeneic hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Hematopoietic tumor
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploring clinical indicators that affect the rate of weight loss in allogeneic hematopoietic stem cell transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Identification of the optimal required calorimetric method
(Evaluate the relationship between the sufficiency rate obtained by dividing the total calorie supply during the period by the 5 types of basal metabolic calorie and the weight loss rate, and identify the optimal necessary calorie measurement method.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
Nutritional intervention
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing allo-SCT using bone marrow catastrophic conditioning (busulfan 6.4 mg/kg, melphalan 140 mg/m2, whole body irradiation: multiple times 8 Gy) at Shizuoka Cancer Center Blood and Stem Cell Transplant Department.
Performance status (PS): PS 0 to 2 before transplantation.
Persons who provide explanations to patients themselves using explanatory documents and obtain written consent from the patients themselves.
Persons who are between 18 and 70 years of age at the time of obtaining consent.
Persons whose body mass index is 18.5 or more and less than 25.0 kg/m2 at the time of obtaining consent.
Key exclusion criteria
Simultaneous active multiple cancers.
Case with severe complications.
Cases of metastasis to the central nervous system with symptoms.
Case of pregnancy or breastfeeding.
Case with mental disorder.
Cases who answered that they were concerned about the amount of intake recorded on food tags.
Cases judged to be inappropriate by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Aoyama |
Organization
Shizuoka Cancer Center
Division name
Dietary Department
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
0559895222
t.aoyama@scchr.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Aoyama |
Organization
Shizuoka Cancer Center
Division name
Dietary Department
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL
0559895222
Homepage URL
t.aoyama@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
Tel
0559895222
t.aoyama@scchr.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
T2022-5-2023-1-4
Org. issuing International ID_1
Shizuoka Cancer Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056389
