UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022411 |
|---|---|
| Receipt number | R000025807 |
| Scientific Title | Retrospective cohort study of the falls of breast cancer patients with chemotherapy-induced peripheral neuropathy |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2019/11/24 09:12:14 |
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Basic information
Public title
Retrospective cohort study of the falls of breast cancer patients with chemotherapy-induced peripheral neuropathy
Acronym
Retrospective cohort study of the falls of breast cancer patients with CINP
Scientific Title
Retrospective cohort study of the falls of breast cancer patients with chemotherapy-induced peripheral neuropathy
Scientific Title:Acronym
Retrospective cohort study of the falls of breast cancer patients with CINP
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For the outpatient breast cancer patients receiving Taxane-based anticancer drugs which develop the CIPN with high frequency, to clarify the frequency of falls/near falls and the factors related to them.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of falls
Key secondary outcomes
The frequency of near falls
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Breast cancer patient
(2) Outpatient breast cancer patients aged 20 to 74, who received Taxane-based anticancer drugs anytime between January 1, 2013 to August 31, 2015, and have developed the symptoms of CIPN (CTCAE Grade 1 or more)
(3) Fluent in Japanese speaking, reading, and writing
Key exclusion criteria
1.The patient now developing cognitive/mental disorder, who is considered difficult for participating in the study by the physician
2.ECOG: PS3-4
3.Patient with brain metastasis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Komatsu |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 1608582
TEL
03-5363-3733
komah@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 1608582
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Faculty of Nursing and Medical Care, Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development
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
YES
Study ID_1
243
Org. issuing International ID_1
Faculty of Nursing and Medical Care, Keio University
Study ID_2
15-R026
Org. issuing International ID_2
St Luke's International Hospital
IND to MHLW
Institutions
Institutions
聖路加国際病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 25 | 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
| 2016 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Subjective evaluation of CIPN
2.Functional status (Vulnerable Elders Survey)
3.Physical and environmental factor (Shortened version of risk of fall score)
4.History of incidence of falls/near falls
5.Personal background and lifestyle
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025807
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
