DOI: 10.1101/19012583Nov 22, 2019Paper

Olanzapine for the Prevention and Treatment of Nausea and Vomiting Induced by Chemotherapy for Lung Cancer: protocol for a multicenter, double-blind and randomized controlled trial

MedRxiv : the Preprint Server for Health Sciences
Jianguo ZhouM. Hu

Abstract

Background: Chemotherapy-induced nausea and vomiting (CINV) is frequently observed after the administration of chemotherapy and significantly influences the quality of life (QoL) of patients. Olanzapine has a high control rate of CINV in patients with cancer when combined with the NK-1 receptor antagonist dexamethasone and 5- hydroxytryptamine (5-HT3) receptor antagonists. The efficacy of a regimen without an NK-1 receptor antagonist remains unknown. Therefore, we designed this randomized trial to provide evidence for the management of CINV. Methods and ananlysis: This is a double-blind, multicenter and randomized controlled trial. Patients with histologically confirmed lung cancer will be assessed by physicians based on the inclusion and exclusion criteria, and 156 participants will be enrolled and randomized to a placebo group or experiment group to receive treatment for CINV. The primary endpoint is the incidence of delayed CINV. The secondary endpoints are complete response (CR) of acute CINV, CR of delayed CINV, effective control rate (ECR) of CINV and QoL. During the six days after administration, these endpoints will be evaluated and recorded by physicians.

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