UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014700 |
|---|---|
| Receipt number | 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 09:03:14 |
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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
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
arinaga@med.tohoku.ac.jp
Public contact
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
arinaga@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017086
