UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032716 |
|---|---|
| Receipt number | R000037131 |
| Scientific Title | The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors regorafenib |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/05/29 11:01:06 |
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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 regorafenib
Acronym
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors regorafenib
Scientific Title
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors regorafenib
Scientific Title:Acronym
The development of new preventive measures and therapeutic methods in the management of hand-foot syndrome by multi-kinase inhibitors regorafenib
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether or not hand-foot syndrome can be more effectively prevented by applying aluminum chloride with anti-perspiration effect to the skin and by detachable/attachable wound dressing to prevent hand-foot syndrome from progressing to grade 2 after grade 1 hand-foot syndrome develops in addition to conventional urea-containing topical treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Incidence of Grade 3 HFS
Key secondary outcomes
Incidence of hand-foot syndrome including all grades, duration until the initial presentation of hand-foot syndrome, duration until the presentaion of hand-foot syndrome with more than grade 2, duration between the presentation of hand-foot syndrome with more than grade 2 and the improvement in the symptoms with the grade decreased to grade 1 or 0, the incidence of cases with reducing the dose of Regorafenib due to hand-foot syndrome, incidence of drug withdrawal due to hand-foot syndrome, the incidence of cases with treatment withdrawal due to hand-foot syndrome, incidence of discontinue medication of regorafenib due to hand-foot syndrome, incidence of side effects by alminum chloride
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 and application of wound dressing after the presentation of grade 1 hand-foot syndrome
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 Regorafeniv
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
Japanese Foundation For Cancer Research
Division name
Dermatology
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550
TEL
03-3520-0111
aya.nishizawa@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Nishizawa |
Organization
Japanese Foundation For Cancer Research
Division name
Dermatology
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550
TEL
03-3520-0111
Homepage URL
aya.nishizawa@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation For Cancer Research
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 | 07 | 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 | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037131
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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