UMIN-CTR Clinical Trial

Basic information
Public title	Breakthrough for Overcoming Lymph Edema
Acronym	BTOLE
Scientific Title	Breakthrough for Overcoming Lymph Edema
Scientific Title:Acronym	BTOLE
Region	Japan

Condition
Condition	Lymph edema
Classification by specialty	Cardiology Dermatology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Overcoming lymph edema
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Grade of edema (circumference and subcutaneous area of deseased limb on CT)
Key secondary outcomes	Pain (VAS), Grade of lymph congestion (lymph scintigraphy), Skin perfusion pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	cilostazol 6 months 200 mg/2x
Interventions/Control_2	aspirin 6 months 100 mg/1x
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	21 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Japanese adult with lymph edema
Key exclusion criteria	1, cancer carriers 2, patients with remarkable hemorrhage 3, patients with tachycardia or severe ischemic heart disease 4, patients who already took aspirin or cilostazol
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shoji Fukuda
Organization	National Center for Global Health and Medicine
Division name	Department of Cardiovascular Surgery
Zip code
Address	1-21-1 Toyama, Shinjuku, Tokyo 162-8655
TEL	03-3202-7181
Email	sfukuda@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Middle name Last name Naomi Tanuma
Organization	National Center for Global Health and Medicine
Division name	Medical Research Management Office
Zip code
Address	1-21-1 Toyama, Shinjuku, Tokyo 162-8655
TEL	03-3202-7181
Homepage URL
Email	shinzou.gimu@hosp.ncgm.go.jp

Sponsor
Institute	Department of Cardiovascular Surgery, National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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	国立国際医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2010 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 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	2010 Year 09 Month 29 Day
Last modified on	2015 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005121

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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