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A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study) by Yuanyuan Zhao; Yunpeng Yang; Fangfang Gao; Changlu Hu; Diansheng Zhong; Miaozhen Lu; Zhiping Yuan; Jianqing Zhao; Jidong Miao; Yan Li; Jie Zhu; Chunbin Wang; Jianjun Han; Yanqiu Zhao; Yan Huang; Li Zhang is a Medicine article available to read on EtoBox.

What is A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study) about?

## Summary ## Background Evidence supports prophylactic use of olanzapine for the treatment of chemotherapy-induced nausea and vomiting (CINV). However, most studies to date have focused on patients with single-day highly emetogenic chemotherapy (HEC). Currently, administration of antiemetic therapies for nausea and vomiting induced by multiday chemotherapy regimens remains a challenge. In this study, we evaluated the efficacy of olanzapine combined with triple antiemetic therapy for the prevention of CINV in patients receiving multiday chemotherapy. ## Methods We performed a randomized, double-blind, placebo-controlled phase 3 trial in 22 hospitals. Eligible patients were between 18 and 75 years old, were diagnosed with malignant solid tumors, and they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. All the study participants were scheduled to be treated with chemotherapy regimens containing 3-day cisplatin (3-day total dose ≥75 mg/m^2^). Randomization was computer generated and stratified by gender and chemotherapy treatment history. Allocation was done via an interactive web response system. Enrolled patients were randomly assigned 1:1 to receive eith

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Author

Yuanyuan Zhao; Yunpeng Yang; Fangfang Gao; Changlu Hu; Diansheng Zhong; Miaozhen Lu; Zhiping Yuan; Jianqing Zhao; Jidong Miao; Yan Li; Jie Zhu; Chunbin Wang; Jianjun Han; Yanqiu Zhao; Yan Huang; Li Zhang

Publisher

Elsevier BV

Published

2022

Language

EN

Field

Medicine (Health Sciences)