The Efficacy of Premedication with 10 mg vs 20 mg of Intravenous Dexamethasone for Prevention of Paclitaxel Hypersensitivity Reaction in Gynecologic Cancer Patients: A Non-Inferiority, Randomized Controlled Trial
- Conditions
- ong-term and frequent exposure to dexamethasone in gynecologic oncology patients who received paclitaxel can follow by steroid side effects.Paclitaxel, Hypersensitivity reaction, Dexamethasone, 10 mg
- Registration Number
- TCTR20220913007
- Lead Sponsor
- Endowment fund, Faculty of Medicine, Chiang Mai University
- Brief Summary
A total of 122 patients were included and randomly assigned to receive dexamethasone 10 mg (61 patients) or dexamethasone 20 mg (61 patients). The overall incidence of HSRs in patients who received dexamethasone 10 mg and dexamethasone 20 mg was 9.8% and 13.1%, respectively, the risk difference between dexamethasone 10 mg and dexamethasone 20 mg not exceeding the NI margin of 0.11 (Risk Difference was -0.03, 95% confidence interval (CI) was -0.15 to 0.08).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 122
1) Aged 18 years of age or older
2) Planned to receive carboplatin and paclitaxel regimen (PT) for the first time
3) Normal bone marrow, renal, and liver function
4) No history of dexamethasone and/or paclitaxel allergy
5) No current medication with any steroidal drugs
1. Cardiac diseases such as atrial or ventricular arrhythmia, congestive heart failure, heart block
2. History of myocardial infarction within 6 months
3. Active pulmonary disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of hypersensitivity reaction at time of investigation Hypersensitivity Reactions Grading (common toxicity criteria version 5.0)
- Secondary Outcome Measures
Name Time Method ausea and vomiting within 1-2 week after receive chemotherapy Common toxicity criteria version 5.0