Anti-emetic Prophylaxis With or Without Dexamethasone
NCT05242874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442
Last updated 2024-10-10
Summary
To evaluate the efficacy and safety of a fosaprepitant, tropisetron, and olanzapine antiemetic regimen, with or without dexamethasone, in patients receiving highly emetogenic chemotherapy with epirubicin and cyclophosphamide.
Conditions
- Chemotherapy-induced Nausea and Vomiting
Interventions
- DRUG
-
Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen
Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4.
- DRUG
-
Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen
Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4. Dexamethasone 12 mg on Day 1, followed by 8 mg on Days 2 to 4.
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Principal Investigators
-
Zhenzhen Liu · Henan Cancer Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2023-08-15
- Completion
- 2023-08-15
Countries
- China
Study Locations
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