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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028286
Receipt No. R000032385
Scientific Title The utility of the early intervention by the multi-disciplinary cooperation in the skin reaction due to EGFR inhibitor: Phase II study
Date of disclosure of the study information 2017/09/01
Last modified on 2018/08/02

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Basic information
Public title The utility of the early intervention by the multi-disciplinary cooperation in the skin reaction due to EGFR inhibitor: Phase II study
Acronym The utility of the early intervention by the multi-disciplinary cooperation in the skin reaction due to EGFR inhibitor: Phase II study
Scientific Title The utility of the early intervention by the multi-disciplinary cooperation in the skin reaction due to EGFR inhibitor: Phase II study
Scientific Title:Acronym The utility of the early intervention by the multi-disciplinary cooperation in the skin reaction due to EGFR inhibitor: Phase II study
Region
Japan

Condition
Condition colorectal cancer, head and neck cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Gastrointestinal surgery Oto-rhino-laryngology
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We appear at high frequency in order of rash, dry skin, perionychia, and the skin reaction with the EGFR (epidermal growth factor receptor) inhibitor often causes the treatment cancellation. Therefore skin reaction measures with the supportive care become important. In the current study, we examine a utility of the early intervention by the multi-disciplinary (dermatologist, medical oncologist, head and neck surgeon, digestive organ surgeon, pharmacist, nurse) cooperation in the skin reaction due to EGFR inhibitor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Severe skin reaction incidence
Key secondary outcomes utility of the episode of care sheet
TTF
Chemotherapy cancellation ratio due to the skin reaction

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 No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We conduct an introduction to the chemotherapy center from diagnosis and treatment department, and, in chemotherapy center, a medical oncologist, a pharmacist or a nurse conducts side effect monitoring using an episode of care sheet (the skin reaction monitoring sheet that we made for the purpose of doing multi-disciplinary cooperation smoothly) at chemotherapy enforcement. By severity of the skin reaction, a tumor physician refers you to a dermatologist, and side effect monitoring, a dermatologist intervene after the next treatment.
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 The patients who are given EGFR inhibitor with a newcomer

The patients who have experience using EGFR inhibitors, but do not have skin symptoms at the time of re-administration
Key exclusion criteria The patients that an agreement was not obtained
The patients who have difficulty in side effect monitoring
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shohei Sano
Organization Wakayama Medical University hospital
Division name Pharmacy
Zip code
Address 811-1, Kimiidera, Wakayama-shi
TEL 073-447-2300
Email s-sano@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shohei Sano
Organization Wakayama Medical University hospital
Division name Pharmacy
Zip code
Address 811-1, Kimiidera, Wakayama-shi
TEL 073-447-2300
Homepage URL
Email s-sano@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University hospital
Institute
Department

Funding Source
Organization Self-funding
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 和歌山県立医科大学附属病院(和歌山)Wakayama Medical University hospital

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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
2017 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 07 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 19 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032385

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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