UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009203 |
|---|---|
| Receipt number | R000010804 |
| Scientific Title | Impairments in subjective cognition associated with chemotherapy in patients with breast cancer: a preliminary prospective open study |
| Date of disclosure of the study information | 2012/10/29 |
| Last modified on | 2016/01/29 16:38:26 |
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Basic information
Public title
Impairments in subjective cognition associated with chemotherapy in patients with breast cancer: a preliminary prospective open study
Acronym
Impairments in subjective cognition associated with chemotherapy for breast cancer
Scientific Title
Impairments in subjective cognition associated with chemotherapy in patients with breast cancer: a preliminary prospective open study
Scientific Title:Acronym
Impairments in subjective cognition associated with chemotherapy for 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 subjective cognitive function in patients with breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes are subjective cognitive function scores in the Behavioural Assessment of the Dysexective Syndrome (BADS) (executive function), Rivermead Behavioral Memory Test (RBMT) (behavioral memory), Clinical Assessment for Spontaneity (CAS) (spontaneity) Cognitive Failures Questionnaire (CFQ) (attention). We will perform them within 4 weeks after chemotherapy (T1) and 6 months after T1 (T2), respectively.
Key secondary outcomes
The secondary outcome is objective working memory scores in the Letter-Number Sequencing (LNS) and Spatial Span (SS). The other secondary outcome are Tumor Necrosis Factor-alfa (TNF-alfa) and High sensitivity C-reactive protein (hsCRP), Brain-derived neurotrophic factor (BDNF), and S-100 protein beta submit (S100B). We will perform them within 4 weeks after chemotherapy (T1) and 6 months after T1 (T2), respectively.
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
| Maneuver |
Interventions/Control_1
Subjective cognitive tests including the BADS, RBMT, CAS and CFQ, and objective cognitive tests including LNS and SS will be performed within 4 weeks after chemotherapy (T1) and 6 months after T1 (T2), respectively. The cognitive tests will require 2-3 hours. We will also take 10 cc of blood at each visit. Chemotherapy consists of 3 cycles of Docetaxel + TS-1 (1 cycle = 4 weeks) and 3 following cycles of 5-FU + Epirubicin + Cyclophosphamide, or 3 cycles of Trastuzumab + Paclitaxel.
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
Female
Key inclusion criteria
1) Women with breast cancer who underwent neo-adjuvant chemotherapy.
2) Women capable of consent to this study.
Key exclusion criteria
1) History of radiotherapy.
2) History of other malignant tumors.
3) Comorbidity of serious physical or neuropsychiatric diseases.
4) History of substance use disorders.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Uchida |
Organization
Keio University School of Medicin
Division name
Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine; Inokashira Hospital
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 29 | 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
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2014 | 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
| 2012 | Year | 10 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010804
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