UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002914 |
|---|---|
| Receipt number | R000003401 |
| Scientific Title | Clinical Trial of Cooling Gel pad for prevention of hand and foot syndrome caused by lyposomal doxorubicine |
| Date of disclosure of the study information | 2009/12/17 |
| Last modified on | 2012/12/20 11:32:36 |
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Basic information
Public title
Clinical Trial of Cooling Gel pad for prevention of hand and foot syndrome caused by lyposomal doxorubicine
Acronym
CGP for HFS by PLD
Scientific Title
Clinical Trial of Cooling Gel pad for prevention of hand and foot syndrome caused by lyposomal doxorubicine
Scientific Title:Acronym
CGP for HFS by PLD
Region
| Japan |
Condition
Condition
Ovarian cancer
Classification by specialty
| Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of Cooling Gel Pad(CGP) for prevention of hand and foot syndrome(HFS) caused by Pegylated Lyposomal Doxorubicine(PLD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Grade 2 or more severe HFS
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
PLD alone
Interventions/Control_2
PLD plus cooling utilizing CGP
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
1) To be judged as eligible for PLD treatment by treating physician
2) To be 20 years old or more
3) Life expectancy more than 3 months
4) Written informed consent must be provided
Key exclusion criteria
1) No prior treatment by PLD
2) No existence of HFS
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Matsumoto |
Organization
Hyogo Cancer Center
Division name
division of medical oncology
Zip code
Address
13-70, Kitaoji-cho, Akashi, Hyogo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hyogo Cancer Center
Division name
division of medical oncology
Zip code
Address
TEL
078-929-1151
Homepage URL
Sponsor or person
Institute
Hyogo Cancer Center division of medical oncology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 12 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | 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
| 2009 | Year | 12 | Month | 17 | Day |
Last modified on
| 2012 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003401
