About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Olanzapine
- Metoclopramide