UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center rater-blinded study of early intervention with the Hand Incubator for breast-cancer-related lymph edema
Acronym	BEAT-EDEMA trial
Scientific Title	Multi-center rater-blinded study of early intervention with the Hand Incubator for breast-cancer-related lymph edema
Scientific Title:Acronym	BEAT-EDEMA trial
Region	Japan

Condition
Condition	breast cancer-related lymphedema
Classification by specialty	Breast surgery Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of Hand Incubator for early stage of the breast cancer-related lymphedema
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	Change in volume of affected upper limb
Key secondary outcomes	ICG evaluation, L-Dex index,the upper limb volume after using Hand Incubator

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hand Incubator 4weeks
Interventions/Control_2	Without Hand Incubator
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	Patients diagnosed with stage 0 or 1 breast cancer-related lymphedema by L-Dex (L-Dex index increase by 10 or more compared to before surgery) within 12 weeks after breast cancer surgery; condition of ECOG PS 0 or 1.
Key exclusion criteria	Patients undergoing surgery for bilateral breast cancer or with surgical history of the opposite breast; breast cancer stage4; patients who have trauma with deformation, degenerative diseases or inflammatory diseases in the upper extremities, now or in the past; conditions of double cancers, collagen diseases, rheumatoid arthritis, nephrosis, heart failure, insect bites, cellulitis or other edema; conditions of severe interruption in the circulation, congestive heart failure or phlegmasia cerulea dolens; patients with perceptual disorder or sensory disorder at the Hand Incubator attachment site; patients with inflammation, suppuration, painful skin diseases or wounds at the Hand Incubator attachment site; patients with hypersensitivity to vinyl chloride or polyurethane; patients with allergies to ICG, iodine or hydrogel; patients with implanted pacemaker; pregnant or lactating women; patients who are unable to obtain written informed consent; patients judged to be inappropriate for participation to this study.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hitoshi Hirata
Organization	Nagoya University
Division name	Hand Surgery
Zip code
Address	65 Tsurumaicho Showaku, Nagoya ,Aichi , Japan
TEL	052-744-2957
Email	h-hirata@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Katsuyuki Iwatsuki
Organization	Nagoya University
Division name	Hand Surgery
Zip code
Address	65 Tsurumaicho Showaku, Nagoya ,Aichi, Japan
TEL	052-744-2957
Homepage URL
Email	kiwatsuki@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Aichi Cancer Center
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	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 10 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	Terminated
Date of protocol fixation	2017 Year 02 Month 02 Day
Date of IRB	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2019 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030017