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RECRUITING
NCT07208305
PHASE3

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

Sponsor: Affiliated Hospital of Qinghai University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-02-03

Completion Date

2027-12-30

Last Updated

2026-03-04

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, China