UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038944 |
|---|---|
| Receipt number | R000044380 |
| Scientific Title | The multicenter, randomized control trial of outpatient rehabilitation after breast cancer surgery |
| Date of disclosure of the study information | 2019/12/21 |
| Last modified on | 2021/09/03 20:29:27 |
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Basic information
Public title
The multicenter, randomized control trial of outpatient rehabilitation after breast cancer surgery
Acronym
ORBS trial
Scientific Title
The multicenter, randomized control trial of outpatient rehabilitation after breast cancer surgery
Scientific Title:Acronym
ORBS trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To inspect the effectiveness of outpatient rehabilitation after breast cancer surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
active shoulder ROM (range of motion) 3 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1) Outpatient rehabilitation (more than 4 times during 3 months after surgery)
- Shoulder ROM exercise
- Instruction against muscle weakness, axillary web syndrome and pectoralis tightness
2) Home exercise with DVD
Interventions/Control_2
Home exercise without DVD
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
| 74 | years-old | >= |
Gender
Female
Key inclusion criteria
1) >=20 and <=74 years old female
2) ECOG-PS 0-1
3) Having breast cancer surgery with axillary lymph node dissection
4) Having written informed consent
Key exclusion criteria
1) Bilateral surgery
2) Having medical history of breast cancer surgery
3) Having surgery with breast reconstruction or tissue expander insertion
4) Having metastasis before surgery
5) Having medical history of ipsilateral upper limb surgery
6) Having pain or numbness in ipsilateral upper limb before surgery
7) Having shoulder ROM restriction before surgery
8) Having upper-extremity interlimb circumference difference before surgery
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanuma |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Rehabilitation Medicine
Zip code
410-2295
Address
1129 Nagaoka, Izunokuni-shi, Shizuoka 410-2295 JAPAN
TEL
055-948-3111
a.tanuma.sy@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tanuma |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Rehabilitation Medicine
Zip code
410-2295
Address
1129 Nagaoka, Izunokuni-shi, Shizuoka 410-2295 JAPAN
TEL
055-948-3111
Homepage URL
a.tanuma.sy@juntendo.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Juntendo University Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777 JAPAN
Tel
055-989-5222
rinsho_office@scchr.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
| 2019 | Year | 12 | Month | 21 | 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 | 12 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 20 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044380
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
