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

NCT07208305 | Recruiting Phase 3

• 1 other identifier: AHQU-2025003
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea; Vomiting

Keywords

Olanzapine; Metoclopramide; Opioid; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with complete control (CC) in both groups during the study period (0-7 days after the initiation of opioid treatment); CC is defined as: no vomiting attack, no rescue medications are used, and no nausea.

  During the 7-day study period after opioid treatment, the proportion of patients achieving CC was compared between the two groups.

  One week

Secondary Outcomes (11)

• The proportion of patients in the two groups who achieved complete response (CR) during the study period (0-7 days after the initiation of opioid treatment); CR is defined as patients who have no vomiting/retching or rescue medications

  One week

• Proportion of patients adherent to strong opioid therapy during intervention period (Day 0-7) and extended follow-up (Day 8-14).

  Two weeks

• The proportion of patients without nausea in both groups during the study period (0-7 days after the start of opioid treatment);

  One week

• The proportion of patients without vomiting in the two groups during the study period (0-7 days after the start of opioid treatment);

  One week

• During the study period(0-7 days after the initiation of opioid treatment), the median time differences in the first occurrence of nausea and the first occurrence of vomiting between the two groups of patients

  One week

Study Arms (2)

No intervention group

NO INTERVENTION

The group did not receive conventional additional preventive treatment.

Olanzapine plus metoclopramide group

ACTIVE COMPARATOR

The experimental group received olanzapine (2.5mg/ night, oral, taken 30 minutes before opioid drugs on the first day of treatment) plus metoclopramide (10mg/ time, oral, 3 times a day) for 7 days.

Drug: Olanzapine; Drug: Metoclopramide

Interventions

Olanzapine DRUG

Oral olanzapine (2.5mg per night, oral, 30 minutes before taking opioids on the first day of treatment), for 7 consecutive days.

Olanzapine plus metoclopramide group

Metoclopramide DRUG

Metoclopramide (10mg/ time, orally, 3 times a day) was taken orally for 7 days.

Olanzapine plus metoclopramide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with malignant tumors diagnosed by pathology or histology;
• Patients diagnosed with locally advanced or advanced stages by imaging;
• Age ≥ 18 years old;
• The eastern cooperative oncology group (ECOG) performance status of 0-3;
• The expected survival period shall be no less than 4 weeks;
• Moderate or severe cancer pain with a Numerical Rating Scale (NRS) score of ≥ 4 points;
• Be able to take oral medication;
• Initial treatment with potent opioid painkillers (such as morphine, oxycodone, fentanyl, etc.);
• No systemic chemotherapy or radiotherapy was received within one month prior to selection, and no drugs that may induce nausea and vomiting were used.
• There were no gastrointestinal discomforts such as nausea or vomiting at the time of selection, and no intestinal obstruction.
• Possess normal comprehension and communication skills, be capable of completing research evaluations and following research procedures.

You may not qualify if:

• Diabetic patients with a clear diagnosis and poorly controlled blood sugar levels;
• There are symptoms of nausea or vomiting;
• Symptomatic intracranial diseases, such as brain metastases or leptomeningeal metastasis;
• Received chemotherapy drug treatment within one week before the trial medication or during the trial period;
• Receive radiotherapy for the head, abdomen or pelvic cavity within one week before the trial or during the trial;
• New drugs with emetic or antiemetic effects have been used within 48 hours before the start of the trial;
• Patients with severe electrolyte imbalance, abnormal kidney or liver function;
• Patients with gastrointestinal bleeding;
• Pregnant or lactating women;
• Patients diagnosed with breast cancer;
• Those whose electrocardiogram examination indicates heart disease or prolonged QTc interval;
• There is a history of allergy or contraindications to olanzapine or metoclopramide.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Olanzapine; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Central Study Contacts

Jiuda Zhao, Doctor

CONTACT

09716230893; jiudazhao@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: October 6, 2025
• Study Start: February 3, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)