An open-label randomized controlled trial to evaluate the efficacy of antihistamine premedication and infusion prolongation in prevention of hypersensitivity reaction to oxaliplatin.

ABSTRACT: Interventions: Additional intravenous chlorpheniramine 10 mg at 30 minutes before oxaliplatin infusion and oxaliplatin was given in a 3-hour intravenous infusion for all 6 planned cycles of FOLFOX/FOLFIRINOX regimens and 4 planned cycles of CAPOX regimen.,In control group, oxaliplatin was infused in two-hour duration. No adding chlorpheniramine in premedication.;Experimental Drug,Active Comparator Drug;CPM + prolongation oxaliplatin infusion ARM,Controlled ARM Primary outcome(s): incidence of hypersensitivity reaction during oxaliplatin infusion number of event, grade Study Design: Randomized

DISEASE(S): Hypersensitivity Reaction (hsr) Is A Common Toxicity Associated With Oxaliplatin. Oxaliplatin Is A Chemotherapy Mainly Used In Gastrointestinal Malignancies Especially Colorectal Cancer. The Incidences Of Oxaliplatin Induced Hsr Vary From 12% To 25% (1-5) (6-8) (9, 10). Although It Is Usually Mild To Moderate Severity (11), It Could Be Severe (9, 10) And Result In Treatment Discontinuation. Oxaliplatin Induced Hsr Is A Type I Hypersensitivity. It Usually Occurs In Later Cycles Of Treatment Course. In A Common Oxaliplatin Based Regimen, Folfox, It Is More Likely To Firstly Occur In Seventh To Ninth Cycle Of Twelve-cycle Treatment Course.(12). Although Many Studies Identified Risk Factors For Hsrs, The Most Consistent Risk Factor Is The Number Of Oxaliplatin Administered. (13-15) To Date, There Have Been A Few Studies Exploring Preventive Strategies For Oxaliplatin Induced Hsrs. Most Of Them Were Retrospective Or Single-arm Prospective Studies. In This Study, We Conducted A Randomization Controlled Trial To Explore The Efficacy Of Additional Antihistamine Premedication And Infusion Prolongation In Prevention Of Oxaliplatin Induced Hsrs,Oxaliplatin/ Hypersensitivity Reaction (hsr)/ Prevention

PROVIDER: 2570214 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR