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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

By Jian-Guo Zhou, Pei-Jie Li, Su-Han Jin, Da-Hai Liu, Lang Huang, Ming-Ze Cao, Yu Zou, Hu Ma

Posted 22 Nov 2019
medRxiv DOI: 10.1101/19012583

BackgroundChemotherapy-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 ananlysisThis 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. Ethic and disseminationThis study has received approval from the institutional ethical review board of the Affiliated Hospital of Zunyi Medical University (ref approval No. 58). Written informed consent will be signed by all participants prior to enrolling. Participants will be randomly assigned to the experimental group or comparator group by blocked randomization. Article summaryStrengths and limitations O_LIThis study will provide evidence for physicians to find an affordable and effective treatment regimen for CINV through this study. C_LIO_LIBecause of the variety of pharmaceutical companies, medical care and other factors, problem of cost will be further explored in the following studies. C_LIO_LIAlthough the study is designed as a double-blind randomized controlled trial, QoL will be measured by a questionnaire that is filled out by patients themselves. This may influence the conclusions. C_LI

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