UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028286 |
|---|---|
| Receipt number | 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 | 2024/07/24 12:06:09 |
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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
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
s-sano@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 05 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032385
