UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028254 |
|---|---|
| Receipt number | 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 | 2021/07/18 13:35:11 |
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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
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
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
nakamo-miki@umin.ac.jp
Sponsor or person
Institute
Keio University Graduate School of Health Management
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032331
| 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 |
