Hypersensitivity Reaction Docetaxel Dexamethasone Hypersensitivity reaction
Conditions
Interventions
1o mg of dexamethasone IV 30 minutes before Docetaxel injection then 4 mg daily on day 1 and 2 after chemotherapy.,8 mg of dexamethasone twice a day 1 day before Docetaxel injection then 8 mg twice a
Active Comparator Drug,Active Comparator Drug
Low dose dexamethason,High dose dexamethason
Sponsors
Chulalongkorn university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient receiving single agent Docetaxel tri-weekly regimen. Patient has never received Docetaxel. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. Age 18 or older.
Exclusion criteria
Exclusion criteria: Prostate cancer patient receiving Docetaxel with prednisolone for treatment. Patient on steroid within 14 days prior to randomization. Patient on immunosuppressive drug within 30 days prior to randomization. Patient with severe allergic reaction such as, anaphylaxis, severe cutaneous adverse drug reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP)). Patient with history of hypersensitivity reaction grade 3 or higher to taxane based chemotherapy. Patient with underlying disease diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| acute hypersensitivity reaction 21 days CTCAE 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| delayed hypersensitivity reaction 21 days CTCAE 4.0,fluid retention syndrome 21 days CTCAE 4.0,Hyperglycemia 7 days Random plasma glucose | — |
Countries
Thailand
Contacts
Public ContactSitthichai Chanmaniloet
Chulalongkorn Universirty
Outcome results
None listed