UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Combined Physical Therapy for Patients with Lymphedema
Title of the study (Brief title)	Effect of CPT for Lymphedema
Region	Japan

Condition
Condition	Lymphedema
Classification by specialty	Vascular surgery Obsterics and gynecology Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of combined physical therapy for patients with lymphedema.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of volume of lower extremity Lymphedema severity score
Key secondary outcomes	QOL evaluation (SF-36, Euriqol) Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	group intensive combined physical therapy (feasibility study)
Interventions/Control_2	group maintenance combined physical therapy (feasibility study)
Interventions/Control_3	group of reinforcement of compression therapy (main study)
Interventions/Control_4	group of reinforcement of lymph-drainage therapy (main study)
Interventions/Control_5	group of reinforcement of exercise (main study)
Interventions/Control_6	standard therapy (main study)
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. primary secondary lymphedema of unilateral leg 2. patient without intensive combined physical therapy within three months 3. more than 20 years
Key exclusion criteria	1. edema due to other causes 2. edema of upper extremities or body 3. stage 0-lymphedema cancer patient 4. expected life time less than one years
Target sample size	50

Research contact person
Name of lead principal investigator	TETSUYA TSUJI
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Email	daihyou@ml.keio.jp

Public contact
Name of contact person	TETSUYA TSUJI
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Homepage URL
Email	daihyou@ml.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 05 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date	2015 Year 04 Month 15 Day
Date of closure to data entry	2015 Year 05 Month 01 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 01 Month 07 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018754