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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009203
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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