UMIN-CTR Clinical Trial

Basic information
Public title	Association with chemotherapy-induced peripheral neuropathy, physical activity and health-related quality of life among breast cancer patients
Acronym	Association with CIPN, physical activity and HRQOL among breast cancer patients
Scientific Title	Association with chemotherapy-induced peripheral neuropathy, physical activity and health-related quality of life among breast cancer patients
Scientific Title:Acronym	Association with CIPN, physical activity and HRQOL among breast cancer patients
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between CIPN, physical activity and HRQOL among breast cancer patients receiving Taxane-based chemotherapy.
Basic objectives2	Others
Basic objectives -Others	Relationship with CIPN
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective evaluation of CIPN
Key secondary outcomes	Physical activity: International Physical Activity Questionnaire short version(IPAQ short version) HRQOL: Functional Assessment of Cancer Therapy-General(FACT-G)

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	74 years-old >=
Gender	Female
Key inclusion criteria	1) Breast cancer patient 2) Patient aged from 20 to 74 3) Stage I to III at the time of diagnosis 4) Patient who has been treated with Taxane-based chemotherapy currently or in the past 5) Patient who is within 22 days to 2 years after the start of Taxane-based chemotherapy 6) Patient who is judged by primary doctor 7) Patient who gained consent to participate in research
Key exclusion criteria	1) Patient with distant metastasis or recurrence 2) Patient decided by primary doctor that it is not suitable for participating in research because of cognitive/mental disorder 3) Those who cannot understand Japanese to complete the questionnaire 4) ECOG Performance Status of 3 or more
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
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Miki Nakamoto
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Zip code
Address	4411 Endo, Fujisawa-shi, Kanagawa
TEL	0466-49-6265
Homepage URL
Email	nakamo-miki@umin.ac.jp

Sponsor
Institute	Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization	Keio SFC Academic Society
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	2017 Year 08 Month 01 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	2017 Year 07 Month 05 Day
Date of IRB	2017 Year 07 Month 05 Day
Anticipated trial start date	2017 Year 08 Month 02 Day
Last follow-up date	2017 Year 11 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Design: Observational cross-sectional study

Management information
Registered date	2017 Year 07 Month 16 Day
Last modified on	2021 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032331