Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
Summary
This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.
Timeline
- Start
- 2014-08-20
- Primary completion
- 2015-04-04
- Completion
- 2017-06-15
Outcome
Met primary endpoint
paper no chemotherapy-induced nausea was significantly greater with olanzapine than with placebo in the first 24 hours after chemotherapy (74% vs. 45%, P=0.002) PMID 27410922 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 10 mg | Oral |
| Background | Aprepitant | Other / unclassified | 80 mg | Oral |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Dexamethasone | Small molecule | 8 mg | Oral |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Fosaprepitant | Other / unclassified | 150 mg | Intravenous |
| Background | Granisetron | Other / unclassified | 1 mg | Intravenous |
| Background | Granisetron | Other / unclassified | 2 mg | Intravenous |
| Background | Ondansetron | Other / unclassified | 8 mg | Oral |
| Background | Palonosetron | Other / unclassified | 0.25 mg | Intravenous |