1 research outputs found
A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions : the PREMED-F1 study
Purpose. Cetirizine is a less sedative alternative to diphenhydramine for the prevention
of infusion-related reactions (IRR) to paclitaxel. However, its use remains controversial. In this
study, we assessed feasibility for a future definitive non-inferiority trial comparing cetirizine to
diphenhydramine as premedication to prevent paclitaxel-related IRR. Methods. This was a single
center randomized prospective feasibility study. Participants were paclitaxel-naive cancer
patients scheduled to start paclitaxel chemotherapy. They were randomly assigned to receive
either intravenous diphenhydramine 50 mg + oral placebo (control) or intravenous placebo + oral
cetirizine 10 mg (intervention) for their first two paclitaxel treatments. The percentage of eligible
patients completing a first paclitaxel treatment and the recruitment rate were assessed (feasibility
outcomes). Drowsiness was measured at baseline and at selected time points using the Stanford
Sleepiness Scale (SSS) (safety outcome). IRR events were also documented (efficacy
outcome). Results. Among 37 eligible patients, 27 were recruited and randomized (control 13;
intervention 14) and 25 completed the study. The recruitment rate was 4.8 participants/month,
meeting the primary feasibility target. Drowsiness was the main adverse effect associated with
the premedication. The increase in drowsiness compared to baseline (ΔSSS) was greater in the
diphenhydramine group compared to the cetirizine group (median ΔSSS 2 (IQR 3.25) vs median
ΔSSS 0 (IQR 1), p < 0.01) when measured one hour after the premedication administration. One
participant had an IRR and no unexpected serious adverse event occurred. Conclusion. The trial
methods were feasible in terms of recruitment, retention and safety. Cetirizine was significantly
less sedating than diphenhydramine. IRR were infrequent and a larger trial is warranted to confirm
non-inferiority for IRR prevention