Skip to content

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

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 - 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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018392
Enrollment
28
Registered
2015-07-23
Start date
2015-07-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR mutation-positive non-small cell lung cancer

Interventions

Hangeshashin-to and Minocycline

Sponsors

National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactMasao Ichiki

National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine

ichiki@kyumed.jp092-852-0700

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026