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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006578
Receipt No. R000007790
Scientific Title Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Date of disclosure of the study information 2011/10/20
Last modified on 2012/12/28

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Basic information
Public title Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Acronym Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Scientific Title Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Scientific Title:Acronym Pilot study of ceramide cream for the skin toxicity of cetuximab in advanced colorectal cancer.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of ceramide cream for the sikn toxicity of cetuximab use for advanced colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes efficacy for skin toxicity
Key secondary outcomes time to efficacy
safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 ceramide cream
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with skin toxicity of cetuximab uncontrolled with coventional therapy.
2) PS(ECOG) 0 or 1.
3) Patients who can use ceramide cream.
4) Patients who can respond to uestinnaire.
5) Agree with take the pictures of skin toxicity.
6) Life expectancy 3months over.
7)Written informed concent.
Key exclusion criteria 1) Other causes occureing skin toxicity.
2) inappropriate for the study.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Nakamura
Organization Aizawa Hospital
Division name Aizawa comprehensive cancer center
Zip code
Address Honjo 2-5-1, Matsumoto city, Nagano, Japan
TEL +81-263-33-8600
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Aizawa Hospital
Division name Aizawa comprehensive cancer center
Zip code
Address Honjo 2-5-1, Matsumoto city, Nagano, Japan
TEL 0263-33-8600
Homepage URL
Email geka-dr7@ai-hosp.or.jp

Sponsor
Institute Aizawa Hospital
Institute
Department

Funding Source
Organization Aizawa Hospital
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
2011 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2012 Year 11 Month 15 Day
Date of closure to data entry
2012 Year 11 Month 15 Day
Date trial data considered complete
2012 Year 11 Month 15 Day
Date analysis concluded
2012 Year 11 Month 15 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 20 Day
Last modified on
2012 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007790

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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