Hand-foot skin reaction
Conditions
Interventions
Topical administration of 3 FTUs (Fingertip Units) betamethasone ointment to palmoplantar regions once a day at bedtime, from the day before administration of sorafanib
Topical administration of 3 FT
Sponsors
Department of Dermatology, Graduate School of Medicine, Kyoto University
Department of Pancreatic Surgery, Graduate School of Medicine, Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject pathologically or clinically (using clinical imaging and serum tumor marker) diagnosed as having hepatocellular carcinoma 2. Subject not diagnosed as a candidate for local therapies (i.e. surgery, radiofreequency ablation, transcatheter arterial embolization, percutaneous ethanol injection) 3. Subject starting to be administered sorafenib at standard dose (400mg, twice a day) 4. Subject diagnosed as eligible to use sorafenib (details mentioned below) a. Child-Pugh classification, grade A b. ECOG Paformance Status, grade 0 or 1 c. Hemoglobin, equal or more than 8.5 g/dL d. White blood cell count, more than 1500 /uL e. Platelet count, more than 75000 /uL f. Serum total bilirubin, less than 2 mg/dL g. Aspartate aminotransferase and alanine aminotransferase, less than 5 times of upper limits of each facility criteria 5. Subject having a chance for survival for equal or more than 12 weeks 6. Subject capable of punctual visit, drug administration, and clinical examinations 7. Subject agreeing in a consent form before allocation
Exclusion criteria
Exclusion criteria: 1. Subject currently administered oral steroid or topical steroid to palmoplantar lesion 2. Subject administered chemothorapy or molecularly-targeted therapy other than sorafenib 3. Subject experiencing molecularly-targeted therapy, including sorafenib 4. Subject sensitive to betamethasone ointment 5. Subject diagnosed as ineligible to administer sorafenib (details mentioned below) a. Subject having esophageal varices with possible bleeding b. Subject experiencing acute myocardial infarction, unstable angina, heart failure, or cerebrovascular disease) within 12 months c. Subject having present or past history of hepatic encephalopathy d. Subject having brain tumor e. Subject on hemodialysis f. Subject experiencing gastrointestinal bleeding within one month g. Subject currently administered CYP3A4 derivative (i.e. rifampicin) h. Subject having serious complications (arhythmia, equal or more than NCI CTCAE grade 2, or uncontrolled hypertension ) 6. Subject with HIV infection 7. Subject having active double cancer 8. Subject in pregnancy or lactating 9. Subject diagnosed as ineligible by doctor-in-charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equal or more than grade 2 hand-foot skin reaction (Japanese version of CTCAE Ver4.0) observed within 6 weeks after commencing administration of sorafenib | — |
Countries
Japan
Contacts
Public ContactYumi Matsumura
Graduate School of Medicine, Kyoto University Department of Dermatology
Outcome results
None listed