UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007287 |
|---|---|
| Receipt number | R000008590 |
| Scientific Title | Neurological underpinnings of cognitive dysfunctions in breast cancer patients |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2017/02/21 09:28:53 |
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Basic information
Public title
Neurological underpinnings of cognitive dysfunctions in breast cancer patients
Acronym
Neurological underpinnings of cognitive dysfunctions in breast cancer patients
Scientific Title
Neurological underpinnings of cognitive dysfunctions in breast cancer patients
Scientific Title:Acronym
Neurological underpinnings of cognitive dysfunctions in breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Psychiatry | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of operations and hormonal therapy on breast cancer patients' cognitive functions and brain structure.
Basic objectives2
Others
Basic objectives -Others
To clarify the influence of breast cancer therapy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function
Brain structure
Key secondary outcomes
Psychological measurement
Estrogen
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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
Breast cancer patient
Postmenopausal
No history of neoadjuvant therapy
Key exclusion criteria
Previous history of cancer therapy with drug
Metastatic cancer
History of any neurological condition, traumatic brain injury, mental retardation, use of psychotropic medication, drug or alcohol abuse
Any contraindication to undergoing on MRI use
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
Institute of development, aging and cancer, Tohoku university
Division name
Dept.Functional brain imaging
Zip code
Address
Seiryo-cho 4-1 Aoba-ku Sendai-shi Miyagi-ken Japan
TEL
022-717-7988
schiho@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiho Sato |
Organization
Institute of development, aging and cancer, Tohoku university
Division name
ept. Functional brain imaging
Zip code
Address
Sendai-shi Miyagi-ken Japan
TEL
022-717-7988
Homepage URL
schiho@idac.tohoku.ac.jp
Sponsor or person
Institute
Institute of development, aging and cancer, Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Institute of development, aging and cancer, Tohoku university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
東北大学 加齢医学研究所（宮城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0140655
Number of participants that the trial has enrolled
Results
We found a significant interaction between regional grey matter volume (rGMV) in the thalamus (P < 0.05, familywise error (FWE), small volume correction (SVC)) and one attention domain subtest (P = 0.001, Bonferroni correction) after surgery in the patient group compared with the control group. Furthermore, the changes in attention were significantly associated with sevoflurane anesthetic dose (P = 0.032) and marginally associated with rGMV changes in the thalamus (P = 0.07, FWE, SVC) in the Pt group.We found a significant interaction between regional grey matter volume (rGMV) in the thalamus (P < 0.05, familywise error (FWE), small volume correction (SVC)) and one attention domain subtest (P = 0.001, Bonferroni correction) after surgery in the patient group compared with the control group. Furthermore, the changes in attention were significantly associated with sevoflurane anesthetic dose (P = 0.032) and marginally associated with rGMV changes in the thalamus (P = 0.07, FWE, SVC) in the Pt group.
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between breast cancer therapy and cognitive function/brain structure
Prospective study
Case control study
Management information
Registered date
| 2012 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008590
