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
Phase 2
- Conditions
- EGFR mutation-positive non-small cell lung cancer
- Registration Number
- JPRN-UMIN000018392
- Lead Sponsor
- ational Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In 4 weeks time severe diarrhea(onset of Grade 3 or 48 hours or more of Grade 2 of diarrhea) expression rate by Afatinib
- Secondary Outcome Measures
Name Time Method