UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026124 |
|---|---|
| Receipt number | 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 | 2019/08/20 11:32:18 |
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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
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
kiwatsuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030017
