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Aprepitant for the Prevention of PONV in Breast Cancer Patients
NCT02431286Phase 4
Key facts
- Status
- Unknown
- Start
- Oct 2014
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- Instituto do Câncer do Estado de São Paulo
- Modality
- Small Molecules
- Drugs
- aprepitant
- Conditions
- postoperative nausea and vomiting (PONV)
01
Overview
Phase 4, randomised, double-blind trial in postoperative nausea and vomiting (PONV) comparing Aprepitant + Palonosetron + Dexamethasone with Placebo + Palonosetron + Dexamethasone (2 arms). Primary endpoint: Incidence of Postoperative Nausea and Vomiting at 24 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Aprepitant + Palonosetron + Dexamethasone
Aprepitant 80 mg PO 1 hour before surgery, plus IV palonosetron and dexamethasone during surgery.
Placebo + Palonosetron + Dexamethasone
Placebo PO 1 hour before surgery, plus IV palonosetron and dexamethasone during surgery.
03
Who it enrols
Female non-smokers with breast cancer scheduled for mastectomy who are at high risk for postoperative nausea and vomiting (Apfel score 3 or 4).
04
Endpoints
Primary
Incidence of Postoperative Nausea and Vomiting
Secondary
Postoperative Pain
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