UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063244 |
|---|---|
| Receipt number | R000072388 |
| Scientific Title | Associations between Health-Related Quality of Life and Upper Limb Function in Women with Breast Cancer-Related Lymphedema |
| Date of disclosure of the study information | 2026/10/11 |
| Last modified on | 2026/10/11 23:49:31 |
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Basic information
Public title
Association between Quality of Life and Upper Limb Function in Women with Upper Limb Lymphedema
Acronym
Association between Quality of Life and Upper Limb Function in Women with Upper Limb Lymphedema
Scientific Title
Associations between Health-Related Quality of Life and Upper Limb Function in Women with Breast Cancer-Related Lymphedema
Scientific Title:Acronym
Associations between Health-Related Quality of Life and Upper Limb Function in Women with Breast Cancer-Related Lymphedema
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to estimate the association between health-related quality of life and upper-limb function in women with breast cancer-related upper-limb lymphedema.
Basic objectives2
Others
Basic objectives -Others
A secondary objective of this study is to examine differences in health-related quality of life domain scores based on employment status.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema
Key secondary outcomes
Grip strength
Shoulder joint range of motion
Upper arm circumference
International Society of Lymphology (ISL) stage
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with breast cancer-related upper-limb lymphedema
Patients who received treatment at a participating facility
Key exclusion criteria
Patients with bilateral breast cancer-related upper-limb lymphedema
Patients with cognitive impairment, severe mental illness, or systemic disease that interferes with assessment
Patients with insufficient data for analysis
Target sample size
219
Research contact person
Name of lead principal investigator
| 1st name | Daigo |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
daigo.0612@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
daigo.0612@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yoshiko Shinohara Memorial Foundation
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
Human Subjects Committee of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
0334331111
rinri@jikei.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
東京慈恵会医科大学附属病院（東京都）
静岡県立静岡がんセンター（静岡県）
社会医療法人光生病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 11 | 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
219
Results
This study is a secondary analysis using existing data, and the results are scheduled to be published as a research paper.
Results date posted
| 2026 | Year | 10 | Month | 11 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
This study is a secondary analysis using existing data, and the results are scheduled to be published as a research paper.
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 31 | Day |
Other
Other related information
This study is a cross-sectional observational study involving a secondary analysis of existing data.
The primary objective of this study is to examine the association between upper-limb function and Lymph-ICF-UL scores, while a secondary exploratory objective is to compare Lymph-ICF-UL domains based on employment status.
Although this study shares an ethical protocol with UMIN000047491, the target population and research objectives differ.
Management information
Registered date
| 2026 | Year | 10 | Month | 11 | Day |
Last modified on
| 2026 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072388
