UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016492 |
|---|---|
| Receipt number | R000019153 |
| Scientific Title | Evaluation for the effect of rehabilitation on breast cancer patients before postoperative radiotherapy. |
| Date of disclosure of the study information | 2015/02/10 |
| Last modified on | 2019/02/12 12:10:16 |
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Basic information
Public title
Evaluation for the effect of rehabilitation on breast cancer patients before postoperative radiotherapy.
Acronym
Evaluation for the effect of rehabilitation on patient before radiotherapy.
Scientific Title
Evaluation for the effect of rehabilitation on breast cancer patients before postoperative radiotherapy.
Scientific Title:Acronym
Evaluation for the effect of rehabilitation on patient before radiotherapy.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The postoperative rehabilitation on breast cancer patients is expected to improve the shoulder joint motion range. We intend to evaluate the usefulness of rehabilitation before postoperative radiotherapy by the analyzing the images acquired at radiotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stability of irradiation field position of radiotherapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
10 breast cancer patients underwent the evaluation of shoulder joint motion range and rehabilitation before postoperative radiotherapy.
Interventions/Control_2
Breast cancer patients without rehabilitation before postoperative radiotherapy.
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
Male and Female
Key inclusion criteria
1. Breast cancer patients diagnosed to need postoperative radiotherapy.
2. The patients who obtained consent after the explanation of this study by a doctor.
3. The breast cancer patients who hope to undergo the rehabilitation before postoperative radiotherapy.
4. The patients older than 20.
5. The breast cancer patients with disorder of the shoulder joint motion range (patients whose shoulder joint motion range is less than in one among follows in the supine position; flexed position: 160 degree, abducted position: 145 degree, outward rotated position: 90 degree) before postoperative radiotherapy.
6. The patients whose performance status (PS) is 0 or 1.
7. The patients who can receive rehabilitation as an outpatient.
Key exclusion criteria
The patients judged to be unsuitable as subjects by the researcher.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | koshi Mimori |
Organization
Kyushu University Beppu Hospital
Division name
Department of Surgery
Zip code
Address
4546, tsurumibaru, tsurumi, Beppu 874-0838, Japan
TEL
0977-27-1600
ooya@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Ezaki |
Organization
Kyushu University Beppu Hospital
Division name
Rehabilitation of Chronic Disease
Zip code
Address
4546, tsurumibaru, tsurumi, Beppu 874-0838, Japan
TEL
0977-24-5301
Homepage URL
ezaki-5963@beppu.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medical Technology, Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation of Chronic Disease,Kyushu University Beppu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019153
