NCT07208305

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Affiliated Hospital of Qinghai University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients were randomly assigned in a 1:1 ratio to: The study group received olanzapine 2.5mg qn+ metoclopramide 10mg tid po for a total of 7 days for preventive treatment; The control group did not receive preventive treatment. Both groups could receive other treatments recommended by doctors after the appearance of OINV.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	Olanzapine	Oral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.
DRUG	Metoclopramide	Metoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.

Timeline

• Start date: 2026-02-03
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2025-10-06
• Last updated: 2026-03-04

Locations

1 site across 1 country: China