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

NCT07403370 | Recruiting

• 1 other identifier: SDTHEC-IF
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumours; Olanzapine; Nausea and Vomiting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (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 .

  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.

Study Arms (3)

Olanzapine Doses 2.5mg

Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)

Olanzapine Doses 5mg

Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)

Olanzapine Doses 10mg

Drug: Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg)

Interventions

Olanzapine (dose comparison: 2.5 mg, 5 mg, 10 mg) DRUG

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

Olanzapine Doses 10mg; Olanzapine Doses 2.5mg; Olanzapine Doses 5mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with solid tumors received different doses of olanzapine (2.5 mg, 5 mg, 10 mg) as an add-on to standard antiemetic prophylaxis for the prevention of HER-induced nausea and vomiting in adult (≥18 years) patients with solid tumors receiving highly emetogenic regimens.

You may qualify if:

• Olanzapine was used to prevent nausea and vomiting (HER-INV) in solid tumors patients receiving highly emetogenic regimens.
• Randomized controlled trials (RCTs), including conference abstracts if sufficient data are provided.
• Adult patients (≥18 years) with solid tumors receiving highly emetogenic chemotherapy (HEC).
• \. 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).
• \. Any of the other three olanzapine doses or placebo (2.5 mg vs. 5 mg vs. 10 mg, or vs. placebo).
• \. At least one of the pre-specified efficacy or safety outcomes must be reported.

You may not qualify if:

• Non-solid tumors patients, non-randomized studies, observational studies, case reports, reviews.
• Studies involving pediatric populations, non-HEC regimens.
• Studies where olanzapine is used as rescue medication only. Studies with overlapping patient populations (the most recent or complete publication will be selected).

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Department of Medical Oncology

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 11, 2026
• Study Start: January 18, 2026
• Primary Completion: February 15, 2026
• Study Completion: March 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)