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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000026124
Receipt No. R000030017
Scientific Title Multi-center rater-blinded study of early intervention with the Hand Incubator for breast-cancer-related lymph edema
Date of disclosure of the study information 2017/05/10
Last modified on 2019/02/16

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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 Suspended
Date of protocol fixation
2017 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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
2017 Year 02 Month 14 Day
Last modified on
2019 Year 02 Month 16 Day


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

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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