UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013098 |
|---|---|
| Receipt number | R000015275 |
| Scientific Title | A phase II trial of uracil ointment for the prevention of capecitabine induced hand-foot syndrome (HFS): . |
| Date of disclosure of the study information | 2014/02/14 |
| Last modified on | 2023/02/13 11:34:41 |
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Basic information
Public title
A phase II trial of uracil ointment for the prevention of capecitabine induced hand-foot syndrome (HFS): .
Acronym
P2 trial of uracil ointment
Scientific Title
A phase II trial of uracil ointment for the prevention of capecitabine induced hand-foot syndrome (HFS): .
Scientific Title:Acronym
P2 trial of uracil ointment
Region
| Japan |
Condition
Condition
Advanced or recurrent breast cancer
Classification by specialty
| Breast surgery | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this trial is to evaluate the prophylactic efficacy of uracil ointment for capecitabine induced hand-foot syndrome in advanced or recurrent breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and appearance time of Grade 2 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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Uracil ointment application to the palmar and plantar skin.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Histologically confirmed advanced or recurrent breast cancer.
Key exclusion criteria
Had previous treatment with capecitabine.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Taguchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endocrine & Breast Surgery
Zip code
6020841
Address
465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
TEL
0752515534
ttaguchi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Taguchi |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Endocrine & Breast Surgery
Zip code
602-8566
Address
465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
TEL
075-251-5534
Homepage URL
breast@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of medicine
Institute
Department
Personal name
Tetsuya Taguchi
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Reviewer Board, Kyoto Prefectural University of Medicine
Address
465 Kajii-cho Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
Tel
0752515337
rinri@koto.kpu-m.ac.jp
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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 14 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015275
| 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 |
