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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036907
Receipt No. R000042059
Scientific Title Search for management index of systemic edema experienced by breast cancer patients on taxane drug treatment
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/31

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Basic information
Public title Search for management index of systemic edema experienced by breast cancer patients on
taxane drug treatment
Acronym Search for management index of systemic edema experienced by breast cancer patients on
taxane drug treatment
Scientific Title Search for management index of systemic edema experienced by breast cancer patients on
taxane drug treatment
Scientific Title:Acronym Search for management index of systemic edema experienced by breast cancer patients on
taxane drug treatment
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to examine whether interventions that promote awareness of early detection through nutrition guidance and visualization of body water content can prevent the development of generalized edema that occurs in breast cancer patients, for breast cancer patients who are on taxane drug treatment.
Basic objectives2 Others
Basic objectives -Others To examine whether the intervention contributes to the improvement of the quality of life of breast cancer patients
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence frequency of edema during the period from administration of taxane drug to the end of administration
Key secondary outcomes QOL of breast cancer patients during the period from administration of taxane drugs to the end of administration

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Nutritional guidance for taste disorders that appear during taxane therapy
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
80 years-old >
Gender Female
Key inclusion criteria 1) Adult patients over 20 years of age who use taxane drugs in breast cancer patients 2) Patients judged by attending physicians to be able to participate in research 3) If there is heart disease including kidney disease or hypertension, taking diuretic Even if the treatment can be carried out including the medical history
Key exclusion criteria 1) Patients who have seen edema in their extremities before treatment 2) Patients who are mentally unstable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name tomoko
Middle name
Last name IZAWA
Organization Graduate school of Medicine kyoto
university
Division name department of human health science
Zip code 606-8507
Address 53 shogoin-kawahara-cho, sakyo-ku, kyoto
TEL 0757513971
Email tizawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name tomoko
Middle name
Last name IZAWA
Organization Graduate school of Medicine kyoto university
Division name department of human health science
Zip code 606-8507
Address 53 shogoin-kawahara-cho, sakyo-ku, kyoto
TEL 0757513971
Homepage URL
Email tizawa@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate school of Medicine kyoto
university department of human health science
Institute
Department

Funding Source
Organization japan science and technology agancy grant in aid for scientific research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JPN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization kyoto univertiy ethical comittie
Address 53 shogoin-kawahara-cho, sakyo-ku, kyoto
Tel 0757534680
Email ethcom@kuhp.kyoto-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 30 Day
Date of IRB
2019 Year 08 Month 31 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 31 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042059

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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