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NCT03598426 · ClinicalTrials.gov registry record · Phase 3
Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity
A Phase 3 study, sponsored by Loma Linda University.
- Completed
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
NCT03598426 is a Phase 3 study that has completed, run by Loma Linda University. The registered enrollment target is 90 participants.
The verdict
NCT03598426, a Phase 3 study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
Study 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.
Interventions
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-08-08 |
| Est. Completion | 2025-01-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03598426
The ClinicalTrials.gov registry entry for NCT03598426 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dexamethasone is the first listed.
NCT03598426 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03598426 about?
NCT03598426 is a clinical study titled "Conventional Prophylactic Oral Dexamethasone vs Short-course IV Dexamethasone in Paclitaxel Hypersensitivity". 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 preventin...
What is the current status of trial NCT03598426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2018-08-08. Estimated completion is 2025-01-07.
What interventions are being tested in trial NCT03598426?
The interventions under investigation include: Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT03598426?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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