Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity
Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
This study is a single center, prospective, randomized, open-label study aimed at determining
the most effective means of preventing hypersensitivity reactions in gynecologic oncology
patients receiving paclitaxel infusions. The study will therefore provide clinicians with the
best ways of preventing paclitaxel hypersensitivity reactions in their patients during
treatment. Subjects will be randomized using the block randomization method into one of these
three commonly used treatment methods:(1) Conventional method: oral dexamethasone (20 mg),
taking 12 hours and 6 hours prior to paclitaxel infusion and intravenous administration of
histamine-1 (H1), and a histamine-2 (H2)receptor antagonists administered 30 minutes prior to
paclitaxel infusion. (2) Short-course method: intravenous dexamethasone (20 mg), administered
concurrently with H1 and H2 antagonists, 30 minutes prior to paclitaxel infusion. (3)
Combined method: oral dexamethasone (20 mg), taking 12 hours prior to treatment in addition
to intravenous dexamethasone (20 mg), H1 and H2 receptor antagonists administered 30 minutes
prior to paclitaxel infusion. The one-way analysis of variance (ANOVA) would be used to
determine if there is any significant difference between the different strategies that are
used to pre-medicate patients prior to paclitaxel infusion. P-values of less than 0.05 will
be considered statistically significant.