UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012985 |
|---|---|
| Receipt number | R000015167 |
| Scientific Title | The long term effectiveness of self-care program for breast-cancer-treatment-related lymphedema |
| Date of disclosure of the study information | 2014/01/28 |
| Last modified on | 2014/07/29 13:55:48 |
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Basic information
Public title
The long term effectiveness of self-care program for breast-cancer-treatment-related lymphedema
Acronym
self-care program for breast-cancer-treatment-related lymphedema
Scientific Title
The long term effectiveness of self-care program for breast-cancer-treatment-related lymphedema
Scientific Title:Acronym
self-care program for breast-cancer-treatment-related lymphedema
Region
| Japan |
Condition
Condition
breast-cancer-treatment-related lymphedema
Classification by specialty
| Breast surgery | Dermatology | Rehabilitation medicine |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of 6 months' self-care program for breast-cancer-treatment-related lymphedema based on the research of UMIN000007616.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Extracellular fluid/ Intracellular fluid ratio
Key secondary outcomes
upper limb volume
upper volume excess
tissue resistance in upper limb
lymphedema related symptoms
lymphedema self care
Transepidermal Water Loss
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
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, 4)standard self-care
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)unilateral breast-cancer-treatment-related lymphedema
2)>6month from active treatment
3)ECOG PS 0-2
4)CTCAE v4.0 edema:limb Grade1-2
5)>2 L-dex(ECF/ICF ratio)
6)be able to responding questionnaire and self-care
7)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
5)Insertion of metal on upper body
6)flagile skin
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YOKO ARINAGA |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
Address
1Hikarigaoka, Fukushima city
TEL
024-547-1850
arinaga@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YOKO ARINAGA |
Organization
Fukushima Medical University
Division name
School of Nursing
Zip code
Address
1Hikarigaoka, Fukushima city
TEL
024-547-1850
Homepage URL
arinaga@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
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
福島県立医科大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 25 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 25 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2014 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015167
| 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 |
