UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036580 |
|---|---|
| Receipt number | R000041668 |
| Scientific Title | The effectiveness of the rehabilitation for patients after mastectomy and axillary lymph node dissection. |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2020/03/30 17:13:06 |
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Basic information
Public title
The effectiveness of the rehabilitation for patients after mastectomy and axillary lymph node dissection.
Acronym
The effectiveness of the rehabilitation for patients after mastectomy and axillary lymph node dissection.
Scientific Title
The effectiveness of the rehabilitation for patients after mastectomy and axillary lymph node dissection.
Scientific Title:Acronym
The effectiveness of the rehabilitation for patients after mastectomy and axillary lymph node dissection.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To research the progress of rehabilitation , the change of the quality of life, the developing axillary web syndrome and lymphedema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ROM of shoulder joint
Key secondary outcomes
the lap diameter of the arm round, grip, axillary web syndrome, pain ,HAMD20 ,EQ-5D-5(befor operation ,leaving the hospital , 2 months later of an operation ,3 months later of an operation , 1 years later of an operation)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
For patients who are planning to be under rehabilitation after mastectomy and axillary lymph node dissection.
Key exclusion criteria
The case of axillary lymph node dissection after the sentinel lymph node biopsy ,
dementia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | |
| Last name | Nagai |
Organization
Fukumaya city hospital
Division name
Rehabilitation costs
Zip code
721-8511
Address
Hiroshima Prefect , Fukuyama City Minamizaou 5-23-1
TEL
084-941-5151
shibyou-reha@city.fukuyama.hiroshima.jp
Public contact
Name of contact person
| 1st name | Ikuyo |
| Middle name | |
| Last name | Nagai |
Organization
Fukumaya city hospital
Division name
Rehabilitation costs
Zip code
721-8511
Address
Hiroshima Prefect , Fukuyama City Minamizaou 5-23-1
TEL
084-941-5151
Homepage URL
shibyou-reha@city.fukuyama.hiroshima.jp
Sponsor or person
Institute
Rehabilitation costs of Fukumaya city hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukumaya city hospital
Address
Rehabilitation costs
Tel
084-941-5151
shibyou-reha@city.fukuyama.hiroshima.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
福山市民病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 08 | 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
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observe while doing a rehabilitation.
Management information
Registered date
| 2019 | Year | 04 | Month | 23 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041668
