UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a self-care program for thepatients undergoing lymphaticovenular anastomosis
Title of the study (Brief title)	Development of a self-care program for thepatients undergoing LVA
Region	Japan

Condition
Condition	secondary lymphedema
Classification by specialty	Breast surgery Plastic surgery Rehabilitation medicine Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of preoperative complex decongestive therapy(CDT) on treatment results of LVA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A value of segmental body composition measurement
Key secondary outcomes	Limb circumference length Limb volume Viscoelasticity on skin surface MR image Ultrasonic echo image of the subcutaneous tissue Lymphedema related symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	group of high implementation rate of preoperative CDT
Interventions/Control_2	group of low implementation rate of preoperative CDT
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	1)unilateral secondary lymphedema 2)>=6 month from radiation treatment and /or chemotherapy 3)got the medical doctore's approval to take CDT, LVA and some medical devices n this study(e.g. MRI) 4)already applied with compression garment
Key exclusion criteria	1)Cancer recurrence 2)<6 month from hospital CDT
Target sample size	40

Research contact person
Name of lead principal investigator	Chika Oshima
Organization	Nagoya University, Graduate School of Medicine
Division name	Department of Nursing
Address	1-1-20 Daiko-minami Higashi-ku Nagoya city, Aichi 461-8673 Japan
TEL	052-719-3101
Email	chika@met.nagoya-u.ac.jp

Public contact
Name of contact person	Chika Oshima
Organization	Nagoya University, Graduate School of Medicine
Division name	Department of Nursing
Address	1-1-20 Daiko-minami Higashi-ku Nagoya city, Aichi 461-8673 Japan
TEL	052-719-3101
Homepage URL
Email	chika@met.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University, Graduate School of Medicine, Department of Nursing
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
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	2017 Year 12 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 22 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 28 Day
Last modified on	2017 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034433