Cancer patients treated with an EGFR inhibitor
Conditions
Interventions
Adapalene gel 0.1% + skin moisturizers + minocycline
Placebo gel + skin moisturizers + minocycline
Sponsors
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who had histologically or cytologically confirmed malignancy 2) Patients who plan the treatment with EGFR inhibitor 3) Age >=20 years 4) ECOG performance status of 0,1,2 5) Fulfil all following conditions i) AST and ALT less than 2.5-times the upper limit of normal (If a patient have liver metastasis, AST and ALT less than 5-times the upper limit of normal) ii) Total-bilirubin 2.0 mg/dL or less 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Previous history of chemotherapy with anti EGFR antibody 2) Past history of severe allergic reaction or history of hypersensitivity or allergy for study drugs 3) Cutaneous symptom of the face 4) Patients receiving irradiation of the face 5) Complications or history of interstitial pneumonia, pulmonary fibrosis 6) Severe complications 7) Pregnancy, possible pregnancy or breastfeeding. 8) Unstable psychic disorder 9) Continuous systemic steroid treatment 10) Decision of ineligibility by a physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference (placebo side - adapalene side) of total acne-like lesion count at 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The investigator's global assessment by dermatologists at 4 weeks The incidence of grade2-3 rash acneiform (MASCC scale) of face within 4 weeks The time to appearance of rash acneiform The rate of complete control of rash acneiform The rate of adverse events The adherence of prophylactic treatment | — |
Countries
Japan
Contacts
Public ContactToru Mukohara
Kobe University Hospital Cancer Center
Outcome results
None listed