UMIN-CTR Clinical Trial

Public title

Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor

Acronym

Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor

Scientific Title

Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor

Scientific Title:Acronym

Examination of mechanism and the skin physiology change regarding the anti-inflammation action of minocycline in the skin disorders of the epithelium growth factor receptor inhibitor

Region

Japan

Condition

Lung cancer(adenocarcinoma)
Skin disorder(acneiform eruption)

Classification by specialty

Pneumology	Hematology and clinical oncology	Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Others

Basic objectives2

Others

Basic objectives -Others

For EGFR gene-positive progress lungs adenocarcinoma, We examine mechanism and a skin physiologic change for the dermatopathy (acneiform eruption) to develop in Japanese in a treatment example frequently in the EGFR-TKI first time.
We examine the mechanism of the anti-inflammatory effect on dermatopathy of EGFR-TKI of the minocycline in addition.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Examination of the mechanism of the anti-inflammatory effect of the minocycline and the pathophysiology of the dermatopathy of EGFR-TKI in biopsy specimens

Key secondary outcomes

Examination of biomarker of the dermatopathy by a skin physiologic change.
Quantification of cytokine and severity(CTCAE ver.4) of the anti-inflammatory effect of the minocycline.
Safety after the minocycline internal use.
Examination of an effect of EGFR-TKI and skin toxicity.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We plan participation registration of 20 cases to check the condition of a patient of the dermatopathy of EGFR-TKI which is end-point and the mechanism of the anti-inflammatory effect of the minocycline and do it with up to five years for the study period.
It is a test method, but the moisturizing agent starts use at the same time from the EGFR-TKI starting date.We measure a water content of the stratum, quantity of sebum and TEWL (transepidermal water loss), pH, skin apparatus measurement(1st) and perform tape stripping before start of therapy in skin biopsy(1st)( H.E. staining, immunohistochemical staining of inflammatory cytokine and quantification).
We add external preparation of the steroid by Grade1 (G1) appearance of the acneiform eruption(CTCAE.ver4.).
We perform skin biopsy(2nd) and above-mentioned skin apparatus measurement(2nd) and tape stripping when drug eruption turned worse in Grade2 (G2) and start minocycline internal use more.
We perform skin biopsy(3rd) and above-mentioned skin apparatus measurement(3rd) and tape stripping after minocycline internal use two weeks later.
When acneiform eruption does not reach G2, We perform skin biopsy(2nd) and above-mentioned skin apparatus measurement(2nd) and tape stripping as of four weeks later. Within a follow-up period, We do not perform biopsy, the skin apparatus measurement afterwards even if acneiform eruption becomes G2. We assume it only follow-up.
When acneiform eruption reaches G3, the skin biopsy and the above-mentioned skin apparatus measurement and tape stripping cancel the final examination after the third minocycline internal use two weeks later without performing them and introduce to dermatologist.
In addition, We are limited to a complier about the skin biopsy.
At the time of each medical examination, We evaluate the QOL using Skindex-16 which area skin disease standard, subjective symptoms, objective symptoms and these inspection items.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)The patient whom the diagnosis of the pulmonary adenocarcinoma established pathologically.
2) It is confirmed from an organization specimen by an insurance approved method to be EGFR gene variation-positive(exon19 deletion, exon21 L858R variation).
3) In an EGFR-TKI untreated recurrence, progress example, is, a dosage planned patient of gefitinib,erlotinib or afatinib.
4) ECOG performance status 0-1.
5)A main organ (marrow, heart, the lungs, the liver, kidney,etc) does not have a high obstacle.
Specifically, as for the marrow function, there are not obstacles more than grade3. As for the cardiac function, the liver function, the renal function, there are not obstacles more than grade2.As the breathing function does not have a interstitial pneumonia and there are not obstacles more than grade2.
6)20 years old or older, the sex does not matter.
7) After enough explanation of examination contents was carried out before final examination registration, a written agreement is provided from a patient.

Key exclusion criteria

1)The patient with history of the EGFR inhibitor treatment.
2)The patient who applied steroid ointment and retinoid or a drug having retinoid-like action to the skin part that was measurement subject within two weeks before clinical trial start.
3)The patient who takes steroid and the minocycline internal use.
4)Complications of a wide range of skin or the patient who has the past. (burn, psoriasis, scleroderma etc.)
5)The patient who received drug-caused skin eruption within two weeks before clinical trial start.
6)A patient with the past of sensitivity to heparin resemblance material component preparation.
7)A patient with hemorrhagic blood disorder(hemophilia, more than grade3 thrombocytopenia, purpura)
8)The patient that it is expected that a few bleeding causes a serious result.
9)A case having serious complications(liver damages more than grade2, renal damage etc.).
10)The patient who internal use is difficult, and has severe diarrhea (more than grade2).
11)The patient with overlap cancer of the activity.
12)A nursing girl and the patient who may be pregnant.
The patient who judges that a clinical study doctor (clinical study responsibility doctor,) is inadequate for reasons of others.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Chigusa Shimono

Organization

Wakayama medical university

Division name

Third department of internal medicine,Oncology center

Zip code

Address

Kimiidera 811-1,Wakayama city, Wakayama, in Japan

TEL

073-447-2300

Email

cshimono@wakayama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Chigusa Shimono

Organization

Wakayama medical university

Division name

Third department of internal medicine,Oncology center

Zip code

Address

Kimiidera 811-1,Wakayama city, Wakayama, in Japan

TEL

073-447-2300

Homepage URL

Email

cshimono@wakayama-med.ac.jp

Institute

Wakayama medical university
Third department of internal medicine,Oncology center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

和歌山県立医科大学附属病院/Wakayama medical university hospital

Date of disclosure of the study information

2016

Year

10

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

01

Month

21

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

01

Day

Last follow-up date

2018

Year

11

Month

13

Day

Date of closure to data entry

2018

Year

11

Month

13

Day

Date trial data considered complete

2018

Year

12

Month

31

Day

Date analysis concluded

2018

Year

12

Month

31

Day

Other related information

Registered date

2016

Year

10

Month

02

Day

Last modified on

2018

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027926