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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028254
Receipt No. R000032331
Scientific Title Association with chemotherapy-induced peripheral neuropathy, physical activity and health-related quality of life among breast cancer patients
Date of disclosure of the study information 2017/08/01
Last modified on 2018/03/06

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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
Last 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
1st 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 05 Day
Date of IRB
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
2018 Year 03 Month 06 Day


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

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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