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 2018/08/30 21:12:41

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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
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 or person

Institute

National Hospital Organization Disaster Medical Center

Institute

Department

Personal name



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

Value
https://center6.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