UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002914
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Obsterics 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
Email

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
Email

Sponsor
Institute Hyogo Cancer Center division of medical oncology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003401

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.