Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07208305

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

Led by Affiliated Hospital of Qinghai University · Updated on 2026-04-27

222

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with malignant tumors confirmed by pathology or histology
  • Diagnosed with locally advanced or advanced cancer by imaging
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
  • Expected survival of at least 4 weeks
  • Moderate or severe cancer pain with a Numerical Rating Scale (NRS) score of 4 or higher
  • Able to take oral medications
  • Starting treatment with strong opioid painkillers (e.g., morphine, oxycodone, fentanyl)
  • No chemotherapy or radiotherapy within one month prior to selection, and no use of drugs that may cause nausea or vomiting
  • No nausea, vomiting, or intestinal obstruction at the time of enrollment
  • Normal comprehension and communication skills to complete study evaluations and procedures
Not Eligible

You will not qualify if you...

  • Diagnosed diabetes with poorly controlled blood sugar levels
  • Presence of nausea or vomiting symptoms
  • Symptomatic intracranial diseases such as brain metastases or leptomeningeal metastasis
  • Chemotherapy treatment within one week before or during the trial
  • Radiotherapy to head, abdomen, or pelvis within one week before or during the trial
  • Use of new drugs with nausea or anti-nausea effects within 48 hours before starting the trial
  • Severe electrolyte imbalance or abnormal kidney or liver function
  • Gastrointestinal bleeding
  • Pregnant or lactating women
  • Diagnosis of breast cancer
  • Heart disease or prolonged QTc interval seen on electrocardiogram
  • Allergy or contraindication to olanzapine or metoclopramide

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810000

Actively Recruiting

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Research Team

J

Jiuda Zhao, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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