Unique ID issued by UMIN | UMIN000023799 |
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Receipt number | 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 21:12:41 |
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.
The bicarbonate ion bath tablet for dermatopathy due to EGFR-TKI.
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.
The bicarbonate ion bath tablet for dermatopathy due to EGFR-TKI.
Japan |
The patients with non-small cell lung cancer who develop the dermatopathy due to EGFR-TKI.
Pneumology |
Malignancy
NO
To investigate the extent of improvement of dermatopathy by using bicarbonate ion bath tablet.
Safety
Exploratory
Phase I,II
Effects on the dermatophaty after 4 weeks of use. Visual analogue scale will be checked.
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
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.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
10
1st name | |
Middle name | |
Last name | Mitsuhiro Kamimura |
National Hospital Organization Disaster Medical Center
Department of Pulmonology
Midorimachi 3256, Tachikawa, Tokyo,Japan
042-526-5511
tdmckamimura@yahoo.co.jp
1st name | |
Middle name | |
Last name | Mitsuhiro Kamimura |
National Hospital Organization Disaster Medical Center
Department of Pulmonology
Midorimachi 3256, Tachikawa, Tokyo,Japan
042-526-5511
tdmckamimura@yahoo.co.jp
National Hospital Organization Disaster Medical Center
Hotalbum Tansansen Tablet Inc.
Profit organization
Japan
NO
国立病院機構災害医療センター
2016 | Year | 08 | Month | 28 | Day |
Unpublished
Main results already published
2014 | Year | 08 | Month | 27 | Day |
2014 | Year | 10 | Month | 01 | Day |
2016 | Year | 08 | Month | 28 | Day |
2018 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027421
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