UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023799
Receipt No. R000027421
Scientific Title The clinical impact of using bicarbonate ion bath tablet on the management of dermatopathy due to EGFR-TKI in the patients with non-small cell lung cancer.
Date of disclosure of the study information 2016/08/28
Last modified on 2018/08/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The clinical impact of using bicarbonate ion bath tablet on the management of dermatopathy due to EGFR-TKI in the patients with non-small cell lung cancer.
Acronym The bicarbonate ion bath tablet for dermatopathy due to EGFR-TKI.
Scientific Title The clinical impact of using bicarbonate ion bath tablet on the management of dermatopathy due to EGFR-TKI in the patients with non-small cell lung cancer.
Scientific Title:Acronym The bicarbonate ion bath tablet for dermatopathy due to EGFR-TKI.
Region
Japan

Condition
Condition The patients with non-small cell lung cancer who develop the dermatopathy due to EGFR-TKI.
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the extent of improvement of dermatopathy by using bicarbonate ion bath tablet.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Effects on the dermatophaty after 4 weeks of use. Visual analogue scale will be checked.
Key secondary outcomes 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 Bicarbonate ion bath tablet (Sparkling Hot Tab) will be added to daily bathing for 4 weeks.
The water temprature will be set under 42 degrees centigrade and soaking time for the buthtab will be around 10 minutes.
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The patients with dermatopathy who are using EGFR-TKI (gefitinib, erlotinib, afatinib) for more than 2 month.
The extent of dermatopathy remains stable 2 weeks proir to the enrollment.
Those who are expected to continue EGFR-TKI for another 4 weeks after enrollment.
Key exclusion criteria The patients with the history of dermatologic disorder prior to the introduction of EGFR-TKI, for example, atopic dermatitis.
Females with pregnacy and lactation.
Those whom the attending physicians consider not suitable to the clinical study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Department of Pulmonology
Zip code
Address Midorimachi 3256, Tachikawa, Tokyo,Japan
TEL 042-526-5511
Email tdmckamimura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Department of Pulmonology
Zip code
Address Midorimachi 3256, Tachikawa, Tokyo,Japan
TEL 042-526-5511
Homepage URL
Email tdmckamimura@yahoo.co.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center
Institute
Department

Funding Source
Organization Hotalbum Tansansen Tablet Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 国立病院機構災害医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 28 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 Main results already published
Date of protocol fixation
2014 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 28 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.