Efficacy of Lower Dose of Dexamethasone Premedication in Patient Receiving Docetaxel-Based Chemotherapy in Preventing Hypersensitivity Reaction: A Randomized Controlled Trial
- Conditions
- Hypersensitivity ReactionDocetaxelDexamethasoneHypersensitivity reaction
- Registration Number
- TCTR20230713001
- Lead Sponsor
- Chulalongkorn university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method acute hypersensitivity reaction 21 days CTCAE 4.0
- Secondary Outcome Measures
Name Time Method delayed hypersensitivity reaction 21 days CTCAE 4.0,fluid retention syndrome 21 days CTCAE 4.0,Hyperglycemia 7 days Random plasma glucose