Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting
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 olanzapi
| Condition(s) | Nausea, Vomiting |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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; Th |
| Who can participate | Inclusion criteria 1. Patients with malignant tumors diagnosed by pathology or histology; 2. Patients diagnosed with locally advanced or advanced stages by imaging; 3. Age ≥ 18 years old; 4. The eastern cooperative oncology group (ECOG) performance status of 0-3; 5. The expected survival period shall be no less than 4 weeks; 6. Moderate or severe cancer pain with a Numerical Rating Scale (NRS) score of ≥ 4 points; 7. Be able to take oral medication; 8. Initial treatment with potent opioid painkillers (such as morphine, oxycodone, fentanyl, etc.); 9. No systemic chemotherapy or radiotherapy was received within one month prior to selection, and no drugs that may induce nausea and vomiting were used. 10. There were no gastrointestinal discomforts such as nausea or vomiting at the time of sele |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Affiliated Hospital of Qinghai University |
| Locations | Xining, Qinghai, China |
| Start date | 2026-02-03 |
| NCT ID | NCT07208305 |
| Official listing | https://clinicaltrials.gov/study/NCT07208305 |