Compared to intravenous diphenhydramine, oral cetirizine resulted in less drowsiness when utilized as a premedication for the prevention of paclitaxel infusion-related reactions in cancer patients, according to the findings of a randomized, double-blind, prospective, feasibility study. This study reported the feasibility of a clinical trial by comparing the efficacy of cetirizine (second-generation antihistamine) and diphenhydramine (first-generation H1 antihistamine) as a premedication to prevent infusion-related reactions.

The study enrolled paclitaxel-naive cancer people (n=27) scheduled to commence paclitaxel chemotherapy. Participants were randomly segregated into intervention group (n=14) and control group (n=13). Notably, 25 subjects were able to complete the study. For the first two paclitaxel therapy, 50 mg intravenous diphenhydramine + oral placebo was given to the control group or 10 mg oral cetirizine + intravenous placebo was given to the intervention group.

Evaluation of the eligible subjects who completed the first paclitaxel therapy was carried out and the recruitment rate was also evaluated (feasibility endpoints). With the help of Stanford Sleepiness Scale (SSS), the drowsiness was estimated at selected time points and at the baseline (safety endpoints). Infusion-related reactions events were recorded too (efficacy endpoints).

The main side effect linked with premedication was drowsiness. In comparison with the baseline, the increase in drowsiness was higher in the diphenhydramine group when compared to the cetirizine group when estimated 1 hour following administration of the premedicine. Infusion-related reactions were reported in one subject. No unexpected serious side effects were reported. Regarding safety, recruitment, and retention, the trial methodology was feasible.

Hence, cetirizine was considerably less sedating when compared to diphenhydramine. Infusion-related reactions were rare and a larger robust trial is warranted for verifying non-inferiority to prevent infusion-related reactions.