An open-label randomized controlled trial to evaluate the efficacy of antihistamine premedication and infusion prolongation in prevention of hypersensitivity reaction to oxaliplatin.
- Registration Number
- TCTR20210506001
- Lead Sponsor
- Division of Medical Oncology, Faculty of Medicine, Chulalongkorn University
- Brief Summary
Of total 160 patients, HSRs occurred in one (1.3%) and ten (12.5%) patients in intervention and control groups, respectively, p 0.005. The relative risk (RR) was 0.10 (95% CI 0.013-0.763, p 0.026). Among 150 patients receiving complete treatment protocol, HSRs occurred in one (1.3%) and ten (13.2%) patients in intervention and control groups, respectively, p 0.005). One HSR in intervention group was grade I severity while there were four grade I and six grade II HSRs in control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Eligible patients were 18 years of age or older, diagnosed with gastrointestinal cancer and receiving oxaliplatin based chemotherapy including FOLFOX (Fluorouracil, Leucovorin and Oxaliplatin), FOLFIRINOX (Fluouracil, Leucovorin, Irinotecan and Oxaliplatin) or CAPOX (capecitabine and Oxaliplatin). All patients had completed 6 cycles of FOLFOX/FOLFIRINOX or 4 cycles of CAPOX , and plan to receive 6 or 4 more cycles of FOLFOX/FOLFIRINOX or CAPOX , respectively. Patients were in Eastern Cooperative Oncology Group performance-status score of 0 or 2 and had adequate organ function.
The patients with history of oxaliplatin hypersensitivity and currently receiving antihistamine were excluded. Written informed consent was obtained from all patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of hypersensitivity reaction during oxaliplatin infusion number of event, grade
- Secondary Outcome Measures
Name Time Method /A N/A N/A