UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation for the effect of rehabilitation on breast cancer patients before postoperative radiotherapy.
Title of the study (Brief title)	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	koshi Mimori
Organization	Kyushu University Beppu Hospital
Division name	Department of Surgery
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	Tomoya Ezaki
Organization	Kyushu University Beppu Hospital
Division name	Rehabilitation of Chronic Disease
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019153