UMIN-CTR Clinical Trial

Basic information
Public title	A Quasi-randomized, open-label, cross-over trial for development of a self-care program for the patient with secondary lymphedema
Acronym	Development of a self-care program for the patients with secondary lymphedema
Scientific Title	A Quasi-randomized, open-label, cross-over trial for development of a self-care program for the patient with secondary lymphedema
Scientific Title:Acronym	Development of a self-care program for the patients with secondary lymphedema
Region	Japan

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

Objectives
Narrative objectives1	To develop a self-care Complex Decongestive therapy (CDT) program for patient with secondary lymphedema
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A value of segmental body composition measurement after intervention
Key secondary outcomes	Limb circumference length Limb volume Edema volume Viscoelasticity on skin surface Lymphedema related symptoms Lymphedema self-care Physical activity

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	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	Lymphedema self-care including bandaging during night-time
Interventions/Control_2	Lymphedema self-care including bandaging during day-time
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	Female
Key inclusion criteria	1)unilateral secondary lymphedema 2)>=6 month from radiation treatment and/or chemotherapy 3)got the medical doctor's approval to take CDT and some medical devices in this study (e.g. MRI) 5)already applied with compression garment
Key exclusion criteria	1)taking a diuretic 2)Cancer recurrence 3)< 6 month from hospital CDT
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Etsuko Fujimoto
Organization	Graduate school of medicine, Nagoya university
Division name	Fundamental nursing
Zip code
Address	1-1-20, daiko-minami, higasi-ku, Nagoya, JAPAN
TEL	052-719-1568
Email	fujimoto@met.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Keisuke Nakanishi
Organization	Graduate school of medicine, Nagoya university
Division name	Doctoral course
Zip code
Address	1-1-20 Daiko-Minami, Higashi-ku, Nagoya City, JAPAN
TEL	090-9193-9679
Homepage URL
Email	Knakanishi.keisuke@j.mbox.nagoya-u.ac.jp

Sponsor
Institute	Graduate school of medicine
Institute
Department

Funding Source
Organization	Nagoya University
Organization
Division
Category of Funding Organization	Other
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 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially 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	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 05 Month 01 Day
Last modified on	2021 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020172