UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019896 |
|---|---|
| Receipt number | 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 07:32:46 |
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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
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
wshoichi@med.nagoya-cu.ac.jp
Public contact
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
wshoichi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya city university, Dermatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012393
