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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019896
Receipt No. R000012393
Scientific Title Investigating basic information of skin toxicity associated with molecularly-targeted drugs cetuximab and panitumumab, and an evaluation of the usefulness of a topical moisturizer in patients treated for colorectal carcinoma and head and neck cancer.
Date of disclosure of the study information 2015/11/23
Last modified on 2016/02/27

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Basic information
Public title Investigating basic information of skin toxicity associated with molecularly-targeted drugs cetuximab and panitumumab, and an evaluation of the usefulness of a topical moisturizer in patients treated for colorectal carcinoma and head and neck cancer.
Acronym Usefulness of a topical moisturizer for cetuximab and panitumumab-associated skin toxicity in patients with CRC and head and neck cancer.
Scientific Title Investigating basic information of skin toxicity associated with molecularly-targeted drugs cetuximab and panitumumab, and an evaluation of the usefulness of a topical moisturizer in patients treated for colorectal carcinoma and head and neck cancer.
Scientific Title:Acronym Usefulness of a topical moisturizer for cetuximab and panitumumab-associated skin toxicity in patients with CRC and head and neck cancer.
Region
Japan

Condition
Condition colorectal carcinoma and head and neck cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Dermatology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigating basic information of skin toxicity by measuring sebum capacity and water content of the stratum corneum associated with molecularly-targeted drugs cetuximab and panitumumab, and an evaluation of the usefulness of a topical moisturizer in patients treated for colorectal carcinoma and head and neck cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sebum capacity, water content of the stratum corneum, duaring 6 weeks from cetuximab or Panitumumab contained chemotherapy started
Key secondary outcomes skin findings(skin dryness,desquamation), subjective complaints duaring 6 weeks from cetuximab or Panitumumab contained chemotherapy started

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 topical administration of heparinoid twice a day in six weeks
Interventions/Control_2 none
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 Male and Female
Key inclusion criteria Colorectal cancer or head and neck cancer patient administered cetuximab or panitumumab

consent in writing
Key exclusion criteria Patient treated with anti-EGFR antibody drugs before
Patient with retinoid and/or retinoid analog within two weeks of observation period
Patient with large skin problems such as burn, psoriasis, scleroderma
Patient with drug eruption within two weeks of observation period
Patient with hemorrhagic diseases such as hemophilia, thrombopenia, purpura
Patient regarded as ineligible for clinical study by investigator
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shoichi Watanabe
Organization Nagoya city university
Division name Dermatology
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-851-5511
Email wshoichi@med.nagoya-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shoichi Watanabe
Organization Nagoya city university
Division name Dermatology
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-851-5511
Homepage URL
Email wshoichi@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya city university, Dermatology
Institute
Department

Funding Source
Organization spediffied non-profit corporation JASMIN
Organization
Division
Category of Funding Organization Other
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
2015 Year 11 Month 23 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 11 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 22 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 23 Day
Last modified on
2016 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012393

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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