Olanzapine plus metoclopramide to prevent opioid-related nausea and vomiting

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

This trial will test whether a one-week course of low-dose olanzapine plus metoclopramide prevents nausea and vomiting in adults with advanced cancer who are starting strong opioid painkillers.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of Qinghai University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Xining, Qinghai)
• Trial ID: NCT07208305 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized (1:1) trial enrolls adults with locally advanced or metastatic cancer who are initiating potent opioid therapy and have moderate to severe cancer pain. Participants receive either olanzapine 2.5 mg nightly plus metoclopramide 10 mg three times daily for 7 days or no prophylactic antiemetic; both groups may get treatment if OINV appears. Investigators record incidence of opioid-induced nausea and vomiting, time to first episode, duration, opioid use changes, and adverse events during follow-up. The trial is conducted at a single center (Affiliated Hospital of Qinghai University) in Xining, Qinghai.

Who should consider this trial

Good fit: Adults (≥18) with pathologically confirmed locally advanced or metastatic cancer, ECOG 0–3, expected survival ≥4 weeks, able to take oral meds, starting strong opioids for moderate–severe cancer pain (NRS ≥4), and without current nausea, vomiting, or intestinal obstruction.

Not a fit: Patients already experiencing nausea or vomiting, with intestinal obstruction, unable to take oral medication, recently receiving chemotherapy or radiotherapy, or with contraindications to olanzapine or metoclopramide may not benefit from this preventive approach.

Why it matters

Potential benefit: If effective, the combination could reduce how many patients develop opioid-induced nausea and vomiting and lower need for rescue antiemetics.

How similar studies have performed: Olanzapine and metoclopramide have shown benefit for nausea in other contexts (particularly chemotherapy-related nausea), but combined prophylaxis specifically for opioid-induced nausea and vomiting has been less widely tested.

Eligibility criteria

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 selection, and no intestinal obstruction.
11. Possess normal comprehension and communication skills, be capable of completing research evaluations and following research procedures.

Exclusion criteria

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

Where this trial is running

Xining, Qinghai

• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)

Study contacts

• Study coordinator: Jiuda Zhao, Doctor

Conditions Nausea; Vomiting; Olanzapine; Metoclopramide; Opioid