Comparing olanzapine 2.5 mg, 5 mg, and 10 mg to prevent chemotherapy-related nausea and vomiting
Olanzapine 2.5 mg Versus 5 mg Versus 10 mg in Highly Emetogenic Regimens: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
This analysis tests whether lower olanzapine doses (2.5 mg or 5 mg) work as well as the standard 10 mg to prevent nausea and vomiting in adults with solid tumors receiving highly emetogenic chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07403370 on ClinicalTrials.gov |
What this trial studies
This project performs a network meta-analysis of randomized controlled trials that added olanzapine (2.5 mg, 5 mg, or 10 mg) to standard triple antiemetic prophylaxis for adults with solid tumors receiving highly emetogenic chemotherapy. Trials comparing any two doses or comparing a dose to placebo are linked to estimate relative efficacy and safety across all three doses. The analysis includes full publications and conference abstracts when they provide sufficient data, and excludes non-randomized or pediatric studies. Outcomes of interest include prevention of acute and delayed nausea/vomiting and adverse effects such as daytime sedation.
Who should consider this trial
Good fit: The findings are most relevant to adults with solid tumors who are receiving highly emetogenic chemotherapy and who receive olanzapine as part of a triple antiemetic regimen.
Not a fit: Patients who are pediatric, have non-solid tumors, or are not receiving highly emetogenic chemotherapy are outside the study scope and unlikely to benefit directly from these results.
Why it matters
Potential benefit: If lower doses work as well, patients could get the same protection from nausea and vomiting with less daytime sedation and better tolerability.
How similar studies have performed: Randomized trials have shown 10 mg olanzapine prevents chemotherapy-induced nausea and vomiting and several smaller trials suggest 5 mg or 2.5 mg may be effective, but no direct head-to-head RCT has compared all three doses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens. 2. Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided. 3. Adult patients (≥18 years) with solid tumors receiving highly emetogenic chemotherapy (HEC). 3\. Olanzapine at 2.5 mg, 5 mg, or 10 mg, added to a standard triple antiemetic regimen (NK1 receptor antagonist + 5-HT3 receptor antagonist + dexamethasone). 4\. Any of the other three olanzapine doses or placebo (2.5 mg vs. 5 mg vs. 10 mg, or vs. placebo). 5\. At least one of the pre-specified efficacy or safety outcomes must be reported. Exclusion Criteria: 1. Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews. 2. Studies involving pediatric populations, non-HEC regimens. 3. Studies where olanzapine is used as rescue medication only. Studies with overlapping patient populations (the most recent or complete publication will be selected).
Where this trial is running
Jinan, Shandong
- Department of Medical Oncology — Jinan, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.