UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032026 |
|---|---|
| Receipt number | R000032697 |
| Scientific Title | The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors sorafenib. |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2019/04/04 11:24:13 |
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Basic information
Public title
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors sorafenib.
Acronym
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors sorafenib.
Scientific Title
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors sorafenib.
Scientific Title:Acronym
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors sorafenib.
Region
| Japan |
Condition
Condition
Hepastocellular cancer(HCC)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The development of new preventive measures and therapeutic methods using alminium chloride in the management of hand-foot syndrome by multi-kinase inhibitors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Grade 3 HFS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
12 weeks /Application of aluminium chloride ointment once a day
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Cancer patients who are scheduled to be on Sorafeniv.
2)Patients who are scheduled to be on the drugs with standard dosage
3) PS0-1
4) Written informed consent for this study can be obtained from the patients.
Key exclusion criteria
1) Patients with fissure or erosion in the palmoplantar area
2) Patients with a history of sympathectomy
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aya Nishizawa |
Organization
National Defense Medical College
Division name
Dermatology
Zip code
Address
3-2 Namiki, Tokorozawa, Saiama 359-8513
TEL
04-2995-1665
ayanishiza@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Nishizawa |
Organization
National Defense Medical College
Division name
Dermatology
Zip code
Address
3-2 Namiki, Tokorozawa, Saiama 359-8513
TEL
04-2995-1665
Homepage URL
ayanishiza@yahoo.co.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Sientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 30 | 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 | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 24 | 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 | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032697
| 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 |
