Klinische Studie

2023

2023

WHO International Clinical Trials Registry Platform - (2023) vom: 29. Mai Zur Gesamtaufnahme - year:2023

Englisch

Volltext [kostenfrei]

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Medical Condition: 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;Oxaliplatin/ Hypersensitivity reaction (HSR)/ Prevention
Phase: Phase 2
Recruitment Status: Completed
Study Type: Interventional

WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 06-05-2021, Last updated: 2023-06-05

TCTR20210506001
Nil Known

WHO007698674