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
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
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
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
