UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020875 |
|---|---|
| Receipt number | R000024087 |
| Scientific Title | Randomized clinical trial concerning diet for outpatients treated with chemotherapy in Hematology /Clinical Oncology division |
| Date of disclosure of the study information | 2016/02/04 |
| Last modified on | 2024/08/13 16:35:47 |
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Basic information
Public title
Randomized clinical trial concerning diet for outpatients treated with chemotherapy in Hematology /Clinical Oncology division
Acronym
Diet Trial for Hematological Malignacies
Scientific Title
Randomized clinical trial concerning diet for outpatients treated with chemotherapy in Hematology /Clinical Oncology division
Scientific Title:Acronym
Diet Trial for Hematological Malignacies
Region
| Japan |
Condition
Condition
Malignant lymphoma
Multiple myeloma
Myelodysplastic syndrome
Chronic lymphatic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove that the outcome of the patients who can eat anything without any restriction is equal to that of the patients whose diet is restricted to heated-food
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The incidence of infection of Grade 3 or more in the first three cycles
Key secondary outcomes
In the first three cycles,thefollowing are to be evaluated as secondary outcoms:1) the incidence of infection of Grade3 ormore with the obvious focus and with neutropenia, 2)the incidence of infection of Grade3 or more without neutropenia, 3) the incidence of febrile neutropenia of Grade3 or more, 4) the rate of discontinuation of treatment due to infection, 5) the rate of postponement of traetment, 6) the difference in the patients' satisfaction between the two diet groups, and 7) the difference in the nutrition state between the two diet groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The group of the patients who have diet to be restricted only to heated food up to the end of the first three cycles
Interventions/Control_2
The group of the patients who can eat anything without any restriction in the first cycles
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
The patients who are diagnosed as having malignant lymphoma, multiple myeloma, myelodysplastic syndrome,
or chronic lymphocytic lymphoma,
who will be treated with chemotherapy as outpatients at least in one cycle among the first three cycles
Key exclusion criteria
none
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Mizoguchi |
Organization
Komaki City Hospital
Division name
Regional Cooperation Division
Zip code
485-8520
Address
Jobushi 1-20, Komaki , Aichi Prefecture
TEL
0568-76-4131
Renkei@city.komaki.lg.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Mizoguchi |
Organization
Komaki City Hospital
Division name
Regional Cooperation Division
Zip code
485-8520
Address
Jobushi 1-20, Komaki , Aichi Prefecture
TEL
0568-76-4131
Homepage URL
Renkei@city.komaki.lg.jp
Sponsor or person
Institute
Komaki City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Komaki City Hospital IRB
Address
Jobushi 1-20,Komaki,Aichi Prefecture
Tel
0568-76-4131
kch-gen@komakihp.gr.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
小牧市民病院 Komaki City Hospital; and so on.
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 04 | 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
| Delay expected |
Results Delay Reason
Exam suspended
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
Suspended
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024087
