UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033605 |
|---|---|
| Receipt number | R000038322 |
| Scientific Title | Randomized phase II study of TJ-17 and TJ-114 in patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/08/16 11:59:18 |
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Basic information
Public title
Randomized phase II study of TJ-17 and TJ-114 in patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy
Acronym
Randomized phase II study of TJ-17 and TJ-114 in patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy
Scientific Title
Randomized phase II study of TJ-17 and TJ-114 in patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy
Scientific Title:Acronym
Randomized phase II study of TJ-17 and TJ-114 in patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy
Region
| Japan |
Condition
Condition
Secondary lower limb lymphedema
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate efficacy of TJ-17 and TJ-114 in patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy by randomized phase II trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
limb circumference
Key secondary outcomes
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
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TJ-17 8 weeks
Interventions/Control_2
TJ-114 8 weeks
Interventions/Control_3
control
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
| 99 | years-old | > |
Gender
Female
Key inclusion criteria
Patients with lower limb lymphedema after lymphadenectomy for gynecologic malignancy
Key exclusion criteria
women were excluded if they
1) were allergy for TJ-17 or TJ-114
2) had other medical severe conditions (i.e., congestive heart failure, chronic/acute renal disease,nephrotic syndrome, nephrosis, liver failure, or severe psychatric disease)
3) were unable to eat
4) were diagnosed as primary lymphedema
5) were suffered from lower limb vein thrombosis
6) were not suitable for participation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Yoshikawa |
Organization
Nagoya University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2261
n-yoshikawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Yoshikawa |
Organization
Nagoya University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2261
Homepage URL
n-yoshikawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Research Foundation for Oriental Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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）、藤田保健衛生大学坂文種報徳會病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038322
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
