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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032716
Receipt No. 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

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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
Email 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
Email aya.nishizawa@jfcr.or.jp

Sponsor
Institute Japanese Foundation For Cancer Research
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037131

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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