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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014700
Receipt No. R000017086
Scientific Title The effectiveness of self-care program for breast-cancer-treatment-related lymphedema;randomized pilot study
Date of disclosure of the study information 2014/07/29
Last modified on 2016/01/29

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Basic information
Public title The effectiveness of self-care program for breast-cancer-treatment-related lymphedema;randomized pilot study
Acronym The effectiveness of self-care program for breast-cancer-treatment-related lymphedema;randomized pilot study
Scientific Title The effectiveness of self-care program for breast-cancer-treatment-related lymphedema;randomized pilot study
Scientific Title:Acronym The effectiveness of self-care program for breast-cancer-treatment-related lymphedema;randomized pilot study
Region
Japan

Condition
Condition breast-cancer-treatment-related lymphedema
Classification by specialty
Surgery in general Breast surgery Dermatology
Rehabilitation medicine Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purposes of this randomized, controlled pilot study is to assess the effects of the 6 months' self-care program for breast-cancer-treatment-related lymphedema for next randomized controlled study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Extracellular fluid/ Intracellular fluid ratio
Key secondary outcomes upper limb volume
edema volume
Tissue Tonometry
Transepidermal Water Loss
lymphedema related symptoms
lymphedema self care
Health related QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 6 month BCRL self-care program including 1)Super slow radio exercise, 2)Arm exercise using Tai-Chi breathing technique, 3)Self-lymphatic drainage with skin moisturizing care
Interventions/Control_2 standard self-care
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

Not applicable
Gender Female
Key inclusion criteria 1)unilateral breast-cancer-treatment-related lymphedema, CTCAE v4.0 edema:limb Grade >1
2)>6month from active treatment
3)ECOG PS 0-2
4) be able to responding questionnaire and self-care
5)submitted written consent as a participant
Key exclusion criteria 1)Any sign of skin damage or sign of acute inflammation on affected arm
2)cancer recurrence
3)pregnant or attempting conception
4)Insertion of cardiac pacemaker and ICD
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoko Arinaga
Organization Tohoku University
Division name Community Cancer Center Program Graduate School of Medicine
Zip code
Address 4-1 Seiryou-machi, Aoba-ku, Sendai-city
TEL 022-717-7087
Email arinaga@med.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yoko Arinaga
Organization Tohoku University
Division name Community Cancer Center Program Graduate School of Medicine
Zip code
Address 4-1 Seiryou-machi, Aoba-ku, Sendai-city
TEL 022-717-7087
Homepage URL
Email arinaga@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
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 25463419
Org. issuing International ID_1 Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 宮城県:東北大学医学系研究科地域がん医療推進センター、東北大学大学院医学系研究科保健学専攻がん看護学分野、東北大学大学院医科学専攻腫瘍外科学分野、東北大学大学院医学系研究科医科学専攻皮膚科学分野、東北大学病院、東北公済病院、宮城県立がんセンター、一番町きじまクリニック
福島県:福島県立医科大学付属病院、福島県立医科大学器官制御外科学講座、福島県立医科大学衛生学・予防医学講座

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 29 Day
Last modified on
2016 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017086

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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