UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016282 |
|---|---|
| Receipt number | R000018887 |
| Scientific Title | The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2019/01/24 08:28:25 |
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Basic information
Public title
The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer
Acronym
The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer
Scientific Title
The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer
Scientific Title:Acronym
The influence of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the impact of chemotherapy on cognitive function and psychiatric symptoms in patients with breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes are objective cognitive function scores in verbal fluency tasks, a part of Wechsler Memory Scale-Revised (WMS-R), Trail Making Test A/B (TMT-A/B), a part of Wechsler Adult Intelligence Scale-III (WAIS-III). We will perform them before chemotherapy (T1), within a week after the end of 1st kind chemotherapy (T2), within a week after the end of 2nd kind chemotherapy (T3), and more than 3 months after the end of 2nd kind chemotherapy (T4).
Key secondary outcomes
The secondary outcomes are subjective cognitive function scores in Everyday Memory Checklist, QOL scores in Functional Assessment of Cancer Therapy-Breast (FACT-B), psychiatric symptoms scores in Hospital Anxiety and Depression Scale (HADS). We will perform them before chemotherapy (T1), within a week after the end of 1st kind chemotherapy (T2), within a week after the end of 2nd kind chemotherapy (T3), and more than 3 months after the end of 2nd kind chemotherapy (T4).
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
Female
Key inclusion criteria
1) Female patients with incipient breast cance
2) The first use of our outpatient chemotherapy room during this study
Key exclusion criteria
1) Incapable of consent to this study
2) History of chemotherapy during admission
3) History of other malignant tumors
4) History of radiotherapy
5) Existence of brain metastasis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Omori |
Organization
Institute of Health Biosciences, The University of Tokushima Graduate School
Division name
Psychiatry
Zip code
Address
3-8-15 Kuramoto-cho Tokushima, Tokushima
TEL
088-633-7130
seishinka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Tada |
Organization
Tokushima University Hospital
Division name
Psychiatry
Zip code
Address
2-50-1 Kuramoto-cho Tokushima, Tokushima
TEL
088-631-3111
Homepage URL
ytada-psy@umin.net
Sponsor or person
Institute
Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Institute of Health Biosciences, The University of Tokushima Graduate School
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
Address
Tel
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
| 2015 | Year | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objective cognitive function tests, a subjective cognitive test, a QOL test, and a psychiatric symptoms test will be performed before chemotherapy (T1), within a week after the end of 1st kind chemotherapy (T2), within a week after the end of 2nd kind chemotherapy (T3), and over 3 months after the end of 2nd kind chemotherapy (T4). Objective cognitive tests will require about 1 hour.
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018887
