UMIN-CTR Clinical Trial

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
Email	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
Email	yagasaki@sfc.keio.ac.jp

Sponsor
Institute	Faculty of Nursing and Medical Care, Keio University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025807