Trial reportBMC cancer2025
The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial.
Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Pharmacologic de-escalation of dexamethasone during weekly paclitaxel: a randomized phase III trial evaluating safety, endocrine effects, and quality of life.Cancer chemotherapy and pharmacology · 2026Trial
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDexamethasone has been used extensively to prevent hypersensitivity reactions to paclitaxel. However, the optimal dose of dexamethasone is controversial, varying between 20 mg and 10 mg. We conducted this randomized controlled trial to illustrate that these 2 dosages of dexamethasone are non-inferior to the prevention of paclitaxel HSRs.
methodsGynecologic cancer patients who naively receive paclitaxel and carboplatin were invited to participate in this study. All participants received the same premedication with intravenous dexamethasone 20 mg, oral lorazepam 0.5 mg, and intravenous chlorpheniramine 10 mg at the first cycle. If they did not develop hypersensitivity reactions, they were randomized to receive either intravenous 20 mg or 10 mg dexamethasone with the same other premedication. The attending nurse recorded the patient's symptoms regarding hypersensitivity reactions. The main outcome was hypersensitivity reaction events in each arm, with a non-inferiority margin of 0.11.
resultsA total of 122 patients were included and randomly assigned to receive dexamethasone 10 mg (n = 61) or dexamethasone 20 mg (n = 61). The overall incidence of hypersensitivity reactions in patients who received dexamethasone 10 mg and dexamethasone 20 mg was 9.8% and 13.1%, respectively, the risk difference between dexamethasone 10 mg and dexamethasone 20 mg not exceeding the non-inferiority margin of 0.11 (Risk Difference = -0.03, 95% confidence interval = -0.15 to 0.08).
conclusionDexamethasone 10 mg was non-inferior to dexamethasone 20 mg in terms of prevention of paclitaxel hypersensitivity reactions.
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