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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016492
Receipt No. 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

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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
Email 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
Email ezaki-5963@beppu.kyushu-u.ac.jp

Sponsor
Institute Department of Medical Technology, Kyushu University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019153

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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