Status:
RECRUITING
Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
Lead Sponsor:
Affiliated Hospital of Qinghai University
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
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 re...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients with malignant tumors diagnosed by pathology or histology;
- Patients diagnosed with locally advanced or advanced stages by imaging;
- Age: 18 to 80 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.
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT07208305
Start Date
September 30 2025
End Date
December 30 2027
Last Update
October 6 2025
Active Locations (1)
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1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000