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Olanzapine Dose Comparison for the Prevention of HER-INV: A Network Meta-Analysis

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07403370
Enrollment
2493
Registered
2026-02-11
Start date
2026-01-18
Completion date
2026-03-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Olanzapine, Solid Tumours

Keywords

Olanzapine, Network Meta-Analysis, High emetic risk, Nausea and Vomiting, Solid tumours

Brief summary

Olanzapine is an effective antiemetic agent for preventing highly emetogenic regimens-induced nausea and vomiting (HER-INV) in patients receiving highly emetogenic regimens (HER). The optimal dose remains debated, with the standard 10 mg dose often causing significant daytime sedation. Recent evidence suggests that lower doses (2.5 mg and 5 mg) may offer comparable efficacy with improved tolerability. However, no head-to-head randomized controlled trials (RCTs) directly compare all three doses.

Detailed description

To compare the relative efficacy and safety of olanzapine at 2.5 mg, 5 mg, and 10 mg, in combination with standard triple antiemetic prophylaxis, for the prevention of HER-INV in adult patients undergoing HER, using a network meta-analysis (NMA) of RCTs. RCTs comparing any two doses of olanzapine (2.5 mg, 5 mg, 10 mg) in adults with solid tumors. 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. 4. Studies with overlapping patient populations (the most recent or complete publication will be selected). Information Sources: Electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science Core Collection. We will also search clinical trial registries (ClinicalTrials.gov, WHO ICTRP) and manually review reference lists of relevant systematic reviews and included studies. Risk of Bias Assessment: The risk of bias for individual RCTs will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2.0) by two independent reviewers. Subgroup Analyses: Subgroup analyses are planned by treatment regimens (such as: cisplatin-based vs. AC-based et al.).

Interventions

DRUGOlanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)

Olanzapine (dose: 2.5 mg) vs. olanzapine (dose: 5 mg) vs. olanzapine (dose: 10 mg)

Sponsors

Shandong Cancer Hospital and Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The complete response rate of nausea and vomiting in the overall phase (including acuted and delayed phase) by highly emetogenic regimens in solid tummors.Nausea and vomiting complete response was assesed during the treatment period (or during the overall assessment period) after the initiation of highly emetogenic regimens, up to 4 weeks.Nausea and vomiting complete response (CR; no vomiting or retching, no rescue medication) rate in the overall phase (including acuted \[0-24h\] and delayed \[\>24h\] phase ) after highly emetogenic regimens in solid tummors .

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026