drugset / Trial / NCT07208305

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

NCT07208305

Phase 3 Recruiting 222 enrolled Affiliated Hospital of Qinghai University
RandomizedParallel-groupSingle-blindPrevention

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of olanzapine plus metoclopramide in preventing opioid-induced nausea and vomiting (OINV) in adult patients with advanced cancer who are initiating strong opioid therapy. The main questions it aims to answer are: (1) Does the combination of olanzapine and metoclopramide reduce the incidence of OINV? (2)What adverse events do participants experience when taking the combination of olanzapine and metoclopramide? Researchers will compare the olanzapine-metoclopramide combination to a no prophylactic treatment control group to determine whether the combination is effective in preventing OINV. Participants will: Take olanzapine (2.5 mg/day ) and metoclopramide (10 mg three times daily) or receive no prophylaxis for 7 days; Through follow-up, nausea, vomiting, the time of the first attack of nausea and vomiting, the duration of nausea and vomiting, the use of strong opioids and adverse events were evaluated and recorded, as well as the pain score (using NRS) and quality of life (EQ-5D-5L) of the patients were evaluated at baseline and on day 7.

Timeline

Start
2026-02-03
Primary completion
2027-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metoclopramide Small molecule 10 mg Oral
Comparator Olanzapine Small molecule 2.5 mg Oral

Indications

No indication recorded.