Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity
Public ClinicalTrials.gov record NCT03598426. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Conventional Prophylactic Regimen of Oral Dexamethasone Versus Short-course Intravenous Dexamethasone in Preventing Paclitaxel-related Hypersensitivity Reactions in Breast and Gynecologic Oncology Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03598426
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 7, 2018
- Primary completion
- Jan 6, 2025
- Completion
- Jan 6, 2025
- Last update posted
- Jun 8, 2026
2018 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Cancer Center | Loma Linda | California | 92354 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03598426, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03598426 live on ClinicalTrials.gov.