UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047491 |
|---|---|
| Receipt number | R000054157 |
| Scientific Title | Factors involved in the onset and course of lymphedema and their treatment. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/10/15 14:58:16 |
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Basic information
Public title
Factors involved in the onset and course of lymphedema and their treatment.
Acronym
Factors involved in the onset and course of lymphedema and their treatment.
Scientific Title
Factors involved in the onset and course of lymphedema and their treatment.
Scientific Title:Acronym
Factors involved in the onset and course of lymphedema and their treatment.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of lifestyle guidance and exercise therapy interventions provided to breast cancer patients during hospitalization and in the postoperative outpatient setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion
Key secondary outcomes
Grip strength
Quick DASH
Circumferential diameter
Questionnaire
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
| Behavior,custom | Other |
Interventions/Control_1
At the time of hospitalization and postoperative outpatient treatment, (1) guidance and management regarding prevention of lymphedema onset, (2) exercise therapy for expanding the range of motion of the shoulder joint, and intervention are provided.
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) Those who have a diagnosis of breast cancer
(2) Women over 20 years old
(3) Surgery with axillary lymph node dissection
Key exclusion criteria
(1) Those with a diagnosis of bilateral breast cancer
(2) Those with a diagnosis of recurrent breast cancer
(3) Those who have a diagnosis of dementia
(4) Those who have a physical or mental illness that requires medical management
(5) Those who have a history of cerebrovascular disease or orthopedic disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Abo |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
0334331111
abo@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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
03-3433-1111
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
| 2022 | Year | 04 | Month | 18 | 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 | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is ongoing and data is being accumulated.
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054157
| 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 |
