UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017381 |
|---|---|
| Receipt number | R000020172 |
| Scientific Title | A Quasi-randomized, open-label, cross-over trial for development of a self-care program for the patient with secondary lymphedema |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/08/21 10:17:02 |
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Basic information
Public title
A Quasi-randomized, open-label, cross-over trial for development of a self-care program for the patient with secondary lymphedema
Acronym
Development of a self-care program for the patients with secondary lymphedema
Scientific Title
A Quasi-randomized, open-label, cross-over trial for development of a self-care program for the patient with secondary lymphedema
Scientific Title:Acronym
Development of a self-care program for the patients with secondary lymphedema
Region
| Japan |
Condition
Condition
Secondary lymphedema
Classification by specialty
| Breast surgery | Rehabilitation medicine | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a self-care Complex Decongestive therapy (CDT) program for patient with secondary lymphedema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A value of segmental body composition measurement after intervention
Key secondary outcomes
Limb circumference length
Limb volume
Edema volume
Viscoelasticity on skin surface
Lymphedema related symptoms
Lymphedema self-care
Physical activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lymphedema self-care including bandaging during night-time
Interventions/Control_2
Lymphedema self-care including bandaging during day-time
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 secondary lymphedema
2)>=6 month from radiation treatment and/or chemotherapy
3)got the medical doctor's approval to take CDT and some medical devices in this study (e.g. MRI)
5)already applied with compression garment
Key exclusion criteria
1)taking a diuretic
2)Cancer recurrence
3)< 6 month from hospital CDT
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuko Fujimoto |
Organization
Graduate school of medicine, Nagoya university
Division name
Fundamental nursing
Zip code
Address
1-1-20, daiko-minami, higasi-ku, Nagoya, JAPAN
TEL
052-719-1568
fujimoto@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Nakanishi |
Organization
Graduate school of medicine, Nagoya university
Division name
Doctoral course
Zip code
Address
1-1-20 Daiko-Minami, Higashi-ku, Nagoya City, JAPAN
TEL
090-9193-9679
Homepage URL
Knakanishi.keisuke@j.mbox.nagoya-u.ac.jp
Sponsor or person
Institute
Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
| 2015 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020172
| 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 |
