UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044892 |
|---|---|
| Receipt number | R000051272 |
| Scientific Title | Cognitive function in patients with malignant lymphoma undergoing chemotherapy -Relation to physical and mental function and treatment-related factors- |
| Date of disclosure of the study information | 2021/07/17 |
| Last modified on | 2021/09/16 08:42:56 |
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Basic information
Public title
Cognitive function in patients with malignant lymphoma undergoing chemotherapy -Relation to physical and mental function and treatment-related factors-
Acronym
Cognitive function in patients with malignant lymphoma undergoing chemotherapy -Relation to physical and mental function and treatment-related factors-
Scientific Title
Cognitive function in patients with malignant lymphoma undergoing chemotherapy -Relation to physical and mental function and treatment-related factors-
Scientific Title:Acronym
Cognitive function in patients with malignant lymphoma undergoing chemotherapy -Relation to physical and mental function and treatment-related factors-
Region
| Japan |
Condition
Condition
malignant lymphoma
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effect of chemotherapy on cognitive decline in patients with malignant lymphoma during chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Montreal Cognitive Assessment-japan
Key secondary outcomes
Age, gender, Treatment period, PS, IADL, anxiety, fatigue, pain, grip strength, Timed Up and Go Test
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with malignant lymphoma who are hospitalized
Age: 20 years or older at the time of obtaining consent
Performance Status (PS) of 3 or higher
Key exclusion criteria
When the attending physician deems it inappropriate
Patients with psychiatric disorders
Patients with serious cardiac, respiratory, hepatic or renal dysfunction
Patients with malignant lymphoma with primary central nervous system or brain lesions
Patients with a history of dementia
Patients with a history of central nervous system disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | ryota |
| Middle name | |
| Last name | yamaguchi |
Organization
Nagasaki University Hospital
Division name
Rehabilitation Dept.
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City
TEL
0958197200
r-yamaguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | ryota |
| Middle name | |
| Last name | yamaguchi |
Organization
Nagasaki University Hospital
Division name
Rehabilitation Dept.
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki 852-8501,JAPAN
TEL
0958197200
Homepage URL
r-yamaguchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Division of Occupational Therapy, Department of Medical Science, Nagasaki University Graduate School of Biomedical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City
Tel
0958197200
r-yamaguchi@nagasaki-u.ac.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
| 2021 | Year | 07 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051272
