UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036580
Receipt No. 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 2019/04/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Erina
Middle name
Last name Kawasaki
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
Email shibyou-reha@city.fukuyama.hiroshima.jp

Public contact
Name of contact person
1st name Erina
Middle name
Last name Kawasaki
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
Email shibyou-reha@city.fukuyama.hiroshima.jp

Sponsor
Institute Rehabilitation costs of Fukumaya city hospital
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.