Study of Olanzapine Plus Metoclopramide to Prevent Nausea and Vomiting in Adults with Advanced Cancer Starting Strong Opioid Treatment

What this Trial Is About

This trial studies adult patients with advanced cancer who are starting strong opioid therapy. It evaluates whether combined treatment with olanzapine and metoclopramide can prevent nausea and vomiting caused by opioids. The study also monitors adverse events to understand the safety of this combination compared to no preventive treatment. Participants are randomly assigned to either receive olanzapine 2.5 mg once nightly plus metoclopramide 10 mg three times daily for seven days or no preventive treatment. Both groups may receive other treatments if nausea or vomiting occur. The trial lasts one week with a group receiving medication and a control group without preventive drugs. During the study, researchers track nausea, vomiting, time to first symptoms, duration of symptoms, opioid use, adverse events, pain levels using the Numeric Rating Scale, and quality of life with the EQ-5D-5L questionnaire. The main outcome is the percentage of patients with complete control of nausea and vomiting over seven days. Safety and survival rates are also followed up to half a year.

Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting