UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023799 |
|---|---|
| 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 | 2025/03/02 15:25:31 |
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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 | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of Pulmonology
Zip code
1900014
Address
Midorimachi 3256, Tachikawa, Tokyo,Japan
TEL
042-526-5511
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of Pulmonology
Zip code
1900014
Address
Midorimachi 3256, Tachikawa, Tokyo,Japan
TEL
042-526-5511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Disaster Medical Center
Address
Midorimachi 3256, Tachikawa, Tokyo,Japan
Tel
0425265511
tdmckamimura@yahoo.co.jp
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
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
4
Results
All four patients showed significant improvement in dry skin and pruritis during the intervention phase. One patient had a mild re-exacerbation of symptoms during the late intervention phase. During the washout phase as compared to the intervention phase, two patients experienced significantly worsened dryness of the skin, and one patient had worsened pruritis. All patients maintained significant improvement during the washout phase compared to the observation phase.
Results date posted
| 2025 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients receiving care at our institute who had non small cell lung cancer, had received first or second generation EGFR TKI therapy for 2 months or longer, and were experiencing grade 3 or higher dry skin and pruritis on their extremities and trunk were enrolled in the study. Additional eligibility criteria included no medication changes during the 4 weeks prior to enrollment, no change in the grade of skin disorder over the 2 weeks prior to enrollment, an expectation to continue on the EGFR TKI for at least 1 month after the introduction of bath salts, and no preexisting skin conditions prior to initiating EGFR TKI therapy.
Participant flow
The patients were provided with and instructed to use bicarbonate ion bath salts (Sparkling HOT Tab, HOT ALBUM Tansansen Tablet, Inc., Tokyo, Japan) during daily bathing for 4 weeks. Patients used a visual analog scale (VAS) on a daily basis to record the degrees of dry skin and pruritis on the extremities and trunk for 2 weeks prior to starting the use of bath salts (observation phase), during the 4 weeks of using the bath salts (intervention phase), and for 2 weeks after terminating use of the bath salts (washout phase).
Adverse events
In one case, frequent cleansing of the facial skin using bath salts in this patient resulted in the appearance of a mild skin rash, which disappeared with discontinuation of the use of bath salts.
Outcome measures
All four patients showed significant improvement in dry skin and pruritis during the intervention phase.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027421
