UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054459 |
|---|---|
| Receipt number | R000061083 |
| Scientific Title | A pilot study to investigate an effective manual lymph drainage based on ICG lymphography for breast cancer-related lymphedema |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/05/22 14:45:45 |
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Basic information
Public title
A pilot study to investigate an effective manual lymph drainage based on ICG lymphography for breast cancer-related lymphedema
Acronym
Lymphedema treatment using ICG lymphangiography
Scientific Title
A pilot study to investigate an effective manual lymph drainage based on ICG lymphography for breast cancer-related lymphedema
Scientific Title:Acronym
A pilot study to investigate an effective manual lymph drainage based on ICG lymphography for breast cancer-related lymphedema
Region
| Japan |
Condition
Condition
Secondary lymphedema after breast cancer surgery
Classification by specialty
| Breast surgery | Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients with refractory lymphedema who are attending the breast and thyroid surgery outpatient lymphedema nursing outpatient clinic and who are performing appropriate self-care but whose edema has not improved, ICG lymphangiography is performed to confirm changes in lymph flow. . To compare and examine the changes in lymphedema caused by identifying drainable lymph flow and changing self-care methods to direct drainage to that area.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The edema status of the affected upper limb can be determined by measuring the circumference of the upper limb and in-body measurement of extracellular fluid in the upper limb.
Confirm by change in amount.
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A
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
Male and Female
Key inclusion criteria
A
Key exclusion criteria
A
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | makiko |
| Middle name | |
| Last name | seto |
Organization
kitasato university hospital
Division name
department of nursing
Zip code
2520329
Address
kitasato sagamiharacity kanagawa
TEL
0427788111
setomaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | makiko |
| Middle name | |
| Last name | seto |
Organization
kitasato
Division name
departmeno of nursing
Zip code
2520329
Address
kitasato sagamiharacity kanagawa
TEL
0427788111
Homepage URL
setomaki@kitasato-u.ac.jp
Sponsor or person
Institute
kitasato univercity
Institute
Department
Personal name
Funding Source
Organization
kitasato univercity
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
A
Address
A
Tel
0427788111
rinrib@med.kitasato-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
| 2024 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061083
