UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018392
Receipt number R000021298
Scientific Title Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer:Multicenter Phase II study
Date of disclosure of the study information 2015/07/23
Last modified on 2017/04/07 11:12:28

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Basic information

Public title

Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer:Multicenter Phase II study

Acronym

Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer

Scientific Title

Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer:Multicenter Phase II study

Scientific Title:Acronym

Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer

Region

Japan


Condition

Condition

EGFR mutation-positive non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To prove the validity of Hangeshashin-to plus minocycline for diaffhes mucositis oral and rash acneiform by Afatinib

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

In 4 weeks time severe diarrhea(onset of Grade 3 or 48 hours or more of Grade 2 of diarrhea) expression rate by Afatinib

Key secondary outcomes



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

Medicine

Interventions/Control_1

Hangeshashin-to and Minocycline

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Adequate organ function
2) Histologically or cytologically confirmed EGFR mutation-positive non-small cell lung cancer
3) Afatinib has not been administered in the past
4) 20 years or older
5) Estimated life expectancy at least 3 months
6)Performance Status (ECOG) 0-2
7)With written informed consent

Key exclusion criteria

1) over Grade 2 of diarrhea, a severe gastrointestinal disorder
2)over Grade 2 of skinl disorder
3)over Grade 2 of mucositis
4)Interstitial lung disease
5) aldosteronism
6) myopathy
7) hypokalemia
8) uncontrolled complications
9) No pregnancy, during nursing
10) infection of HBV, HCV, and HIV
11). History of sensitivity of Afatinb, Hangeshashin-to and tetracycline antibiotic
12)In addition, the primary doctor judging inappropriate for entry

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Ichiki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Email

ichiki@kyumed.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masao Ichiki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

092-852-0700

Homepage URL


Email

ichiki@kyumed.jp


Sponsor or person

Institute

National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Kyushu Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 23 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

Completed

Date of protocol fixation

2015 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 27 Day

Last follow-up date

2017 Year 06 Month 01 Day

Date of closure to data entry

2017 Year 06 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 23 Day

Last modified on

2017 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021298


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name